Biogen Idec, Inc. (Massachusetts) (BIIB) Submits Application to FDA for Approval of PLEGRIDY™ (Peginterferon Beta-1a) in Multiple Sclerosis
5/21/2013
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TaiGen Biotechnology Announces Submission of New Drug Application for Nemonoxacin in Taiwan and Mainland China
5/16/2013
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Johnson & Johnson (JNJ) Unit Gets Priority Revenue for Simeprevir NDA
5/15/2013
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TWi Pharmaceuticals, Inc. Announces Tentative ANDA Approval for Guanfacine Hydrochloride Extended-Release Tablets
5/14/2013
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Seattle Genetics, Inc. (SGEN) Announces ADCETRIS® (Brentuximab Vedotin) Supplemental BLA Accepted for Filing by the FDA
5/14/2013
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FDA Rejects Endo Health Solutions Inc. (Formerly Known as Endo Pharmaceuticals Holdings Inc.) (ENDP) Petition to Protect Its Painkiller Franchise
5/13/2013
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FDA Accepts Biogen Idec, Inc. (Massachusetts) (BIIB)’s Biologics License Application for First Long-Lasting Factor VIII Therapy for Hemophilia A
5/13/2013
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Janssen Research & Development Release: FDA Grants Priority Review to Simeprevir (TMC435) for Combination Treatment of Genotype 1 Chronic Hepatitis C
5/13/2013
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Actavis (ACT)' NDA for Progestin-Only Patch Accepted for Filing by FDA
5/13/2013
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Pfizer Inc. (PFE) Yet to Decide on Pain Therapeutics Painkiller
5/10/2013
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Merck & Co., Inc. (MRK) Announces FDA Acceptance of Biologics License Application for Investigational Ragweed Pollen Sublingual Allergy Immunotherapy Tablet
5/8/2013
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FDA Committee Turns Down AVEO Oncology (Formerly known as AVEO Pharmaceuticals, Inc.) (AVEO)/Astellas Pharma Inc. (YPH.BE)'s Cancer Drug
5/6/2013
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Gilead Sciences, Inc. (GILD) Fails FDA Approval for Two HIV Drugs in 4-in-1 Pill
5/6/2013
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FDA Delays Approval of Titan Pharmaceuticals (TTP)'s Suboxone Implant
5/1/2013
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CureMark Announces Positive Pre-NDA Meeting With FDA for New Drug Application for CM-AT for Autism
4/23/2013
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Amarin Corporation PLC (AMRN) Announces FDA Acceptance of Supplemental New Drug Application (sNDA) for Vascepa(R) for the Treatment of Patients With High Triglycerides (>200 mg/dL and <500 mg/dL) With Mixed Dyslipidemia
4/23/2013
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Immune Response BioPharma to Seek Emergency Approval of REMUNE in Thailand
4/22/2013
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GlaxoSmithKline (GSK) and Theravance, Inc. (THRX) Announce Regulatory Submission for ANORO™ ELLIPTA™ (UMEC/VI) in Japan
4/22/2013
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FDA Rejects Allergan Inc. (AGN) Migraine Drug on Manufacturing Issues
4/22/2013
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FDA Panel Backs Approval of GlaxoSmithKline (GSK), Theravance, Inc. (THRX) Lung Drug
4/22/2013
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Amarin Corporation PLC (AMRN) Announces Approval of Supplemental New Drug Application for Chemport as Additional Vascepa® Active Pharmaceutical Ingredient Supplier
4/18/2013
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Santarus Inc. (SNTS) and Pharming Group (PHGUF.PK) Announce Submission of RUCONEST Biologics License Application to FDA
4/17/2013
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Sarepta Therapeutics (Formerly known as AVI BioPharma, Inc.) (SRPT) Drops After FDA Asks for More Info
4/17/2013
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DURECT Corporation (DRRX) Announces Submission of New Drug Application for POSIDUR™ (SABER®-Bupivacaine)
4/16/2013
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Biocryst Pharmaceuticals (BCRX) Completes Peramivir Type C Meeting
4/16/2013
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FDA Accepts Otsuka Pharmaceutical Co., Ltd. Tolvaptan NDA for Priority Review
4/16/2013
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Otsuka Pharmaceutical Co., Ltd.'s New Drug Application for Tolvaptan, the Investigational Compound for Autosomal Dominant Polycystic Kidney Disease (ADPKD), Accepted for Review by the FDA
4/12/2013
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BTG plc (BTG.L): Varisolve® NDA Accepted for Full Review by FDA
4/12/2013
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FDA Asks ACADIA Pharmaceuticals, Inc. (ACAD) to Skip Late Stage Study and File NDA After Successful Results
4/11/2013
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Gilead Sciences, Inc. (GILD) Pushes for FDA Blockbuster Approval
4/11/2013
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Merck & Co., Inc. (MRK) NDA for NOXAFIL Accepted by FDA
4/10/2013
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China's SFDA Ready to Fast-Track Approvals of Peramivir, a Flu Treatment
4/9/2013
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Bayer HealthCare AG (BAY): NDA for Riociguat Gets Priority Review
4/8/2013
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New-Look Sarepta Therapeutics (Formerly known as AVI BioPharma, Inc.) (SRPT) Eyes Approval for Muscular Dystrophy Drug
4/5/2013
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Rockwell Medical Technologies (RMTI) Submits Calcitriol Manufacturing Data to FDA for Approval
4/1/2013
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pSivida Corp (PSDV) Reports on Resubmission to FDA of NDA for ILUVIEN® for Chronic Diabetic Macular Edema
4/1/2013
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Biocryst Pharmaceuticals (BCRX) Receives Preliminary Comment Letter From FDA on Peramivir
4/1/2013
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FDA Accepts Merck & Co., Inc. (MRK)'s BLA for Investigational Allergy Immunotherapy Tablet
3/29/2013
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Janssen Research & Development Submits New Drug Application for Simeprevir
3/29/2013
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FDA Rejects A.P. Pharma, Inc. (APPA)'s Cancer Drug
3/28/2013
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Merck & Co., Inc. (MRK) Announces FDA Acceptance of Biologics License Application for Investigational Grass Pollen Allergy Immunotherapy Tablet
3/27/2013
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IntelGenx Corp. Submits New Drug Application for Anti-Migraine VersaFilm™
3/27/2013
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RedHill Biopharma Ltd. (RDHL) Submits New Drug Application to U.S. FDA for RHB-103 Anti-Migraine Oral Thin Film
3/27/2013
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pSivida Corp (PSDV) Takes Another Stab at FDA Approval for Iluvien
3/27/2013
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United Therapeutics Corporation (UTHR) Falls After Hypertension Pill Rejected
3/26/2013
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Vanda Pharmaceuticals, Inc. (VNDA) Reports Successful Completion of Pre-NDA Meeting With FDA on Tasimelteon for the Treatment of Non-24-Hour Disorder in the Totally Blind
3/25/2013
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Boehringer Ingelheim Corporation and Eli Lilly and Company (LLY) Submit New Drug Application to FDA for Empagliflozin, an Investigational Type 2 Diabetes Treatment
3/25/2013
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Novartis AG (NVS) Breast Cancer Drug Rejected Despite Being Hailed as a "Breakthrough"
3/25/2013
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Titan Pharmaceuticals (TTP) Announces FDA Advisory Committee Recommends Approval of Probuphine for the Treatment of Adult Patients With Opioid Dependence
3/22/2013
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pSivida Corp (PSDV) Reports Updates on ILUVIEN® for Planned Resubmission to FDA and European Launch
3/22/2013
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Stellar Biotechnologies, Inc. Submits Biological Master File to FDA for Subunit KLH
3/19/2013
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FDA Rejects Pharmaxis Ltd (PXS.AX) Drug Push Bid
3/19/2013
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Seattle Genetics, Inc. (SGEN) Submits Supplemental BLA to FDA for Retreatment and Extended Duration of Therapy With ADCETRIS® (Brentuximab Vedotin) in Relapsed Hodgkin Lymphoma and Systemic ALCL
3/18/2013
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Biogen Idec, Inc. (Massachusetts) (BIIB) Submits Application to FDA for First Long-Lasting Factor VIII Therapy for Hemophilia A
3/12/2013
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GlaxoSmithKline (GSK) Files for European Approval of Diabetes Drug Albiglutide
3/8/2013
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FDA Rejects Johnson & Johnson (JNJ)'s Xarelto Again for ACS
3/7/2013
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AMAG Pharmaceuticals, Inc. (AMAG) Announces FDA Acceptance of Supplemental New Drug Application for Feraheme Label Expansion to Include Iron Deficiency Anemia Patients Who Cannot Take Oral Iron
3/6/2013
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Nuvo Research Inc. (NRI.TO) Announces FDA Response to PENNSAID® 2% NDA
3/5/2013
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FDA Panel Rejects Depomed, Inc. (DEPO) Menopause Treatment
3/5/2013
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FDA Panel Votes Against Approval of Noven Pharmaceuticals Inc.'s Menopause Drug
3/5/2013
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FDA Accepts Biogen Idec, Inc. (Massachusetts) (BIIB)'s Biologics License Application for First Long-Lasting Factor IX Therapy for Hemophilia B
3/4/2013
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Iroko Pharmaceuticals Announces Acceptance for NDA Filing of Lower Dose Submicron Diclofenac for the Treatment of Mild to Moderate Acute Pain in Adults
3/4/2013
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Pharma Tech Industries Selected to Manufacture Innovative Nasal Delivery System for NDA Submission
3/4/2013
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Menopause Drugs From Depomed, Inc. (DEPO), Hisamitsu Pharmaceutical Offer Benefits
3/1/2013
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QRxPharma Pty Ltd. Resubmits MOXDUO® New Drug Application to the FDA
2/28/2013
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FDA Delays Approval of Zogenix, Inc. Painkiller
2/28/2013
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Titan Pharmaceuticals (TTP) Announces Date of FDA Advisory Committee Review of Probuphine® for the Treatment of Opioid Dependence
2/27/2013
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Sunovion Pharmaceuticals Inc. Announces FDA Acceptance for Review of New Drug Application Resubmission for STEDESA® (eslicarbazepine acetate) as a Once-Daily Adjunctive Therapy for Partial-onset Seizures in Adults With Epilepsy
2/27/2013
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AstraZeneca PLC (AZN) Ready to File Constipation Drug Naloxegol
2/27/2013
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Amarin Corporation PLC (AMRN) Announces Submission of Supplemental New Drug Application (sNDA) for Vascepa® for the Treatment of Patients With High Triglycerides With Mixed Dyslipidemia
2/26/2013
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FDA: Dynavax Technologies Corporation (DVAX) Hep B Vaccine Needs More Evaluation
2/25/2013
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VIVUS, Inc. (VVUS) Diet Pill Rejected Again by EU Regulators
2/22/2013
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Chelsea Therapeutics, Inc. (CHTP) Expects to Resubmit Northera for FDA Approval in 2nd Quarter
2/21/2013
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U.S. Rejection of Novo Nordisk A/S (NVO) Drug Seen Temporary But Costly
2/21/2013
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Depomed, Inc. (DEPO)'s Drug Serada Ready for FDA Approval
2/21/2013
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GlaxoSmithKline (GSK) and Theravance, Inc. (THRX) Announce FDA Acceptance of New Drug Application (NDA) Submission in the U.S. for ANORO ELLIPTA™ for COPD
2/19/2013
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Sanofi (France) (SAN.PA) New Drug Application for Lixisenatide Accepted for Review by FDA
2/19/2013
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Medical Imaging Drugs Advisory Committee Recommends Approval of Guerbet (GBT) NDA for Dotarem® (gadoterate meglumine)
2/15/2013
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IBA Molecular Announces Submittal of ANDA for Ammonia N 13 Injection
2/15/2013
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United Therapeutics Corporation (UTHR) Announces FDA Acceptance of Resubmission of Oral Treprostinil NDA
2/14/2013
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Bayer HealthCare (BAY) Gets FDA Priority Review for Cancer Drug
2/13/2013
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GlaxoSmithKline (GSK) Gets Speedy EU Review for Melanoma Drug
2/12/2013
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Promising Insomnia Pill From Merck & Co., Inc. (MRK) Remains "Critical" to Future Amid Recent Setbacks
2/12/2013
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Novo Nordisk A/S (NVO) Stung by FDA Data Request
2/12/2013
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Bayer HealthCare (BAY)'s Riociguat Submitted for Approval in U.S., EU
2/11/2013
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Eli Lilly and Company (LLY)/Boehringer Ingelheim Corporation Remain Coy on Insulin Glargine's EU, FDA Regulatory Strategies
2/8/2013
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Hemispherx Biopharma (HEB) Says FDA Rejects Fatigue Drug Application
2/5/2013
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FDA Panel Backs Boehringer Ingelheim Corporation COPD Drug
1/31/2013
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Novo Nordisk A/S (NVO) Sticks to Target for First-Half Tresiba Approval in U.S.
1/31/2013
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Spectrum Pharmaceuticals, Inc. (SPPI) Buys Apaziquone Rights From Allergan Inc. (AGN), to File NDA
1/31/2013
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MP Biomedicals, Inc. Submits Biologic License Application (BLA) for FDA Approval of HTLV Confirmatory Test
1/28/2013
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Genzyme Corporation (GENZ)'s LEMTRADA™ (alemtuzumab) Application for MS Accepted for Review by the FDA
1/28/2013
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Impax Pharmaceuticals (IPXL) Fails to Win Approval for Parkinson's Drug
1/23/2013
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Biogen Idec, Inc. (Massachusetts) (BIIB), Elan Corporation PLC (ELN) Makes Play for Bigger Tysabri Market
1/17/2013
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QRxPharma Pty Ltd. and FDA Establish Path Forward for Resubmission of MOXDUO® New Drug Application
1/16/2013
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FDA Grants Priority Review to Boehringer Ingelheim Corporation’s Afatinib* NDA for EGFR Mutation-Positive Advanced NSCLC
1/16/2013
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Astellas Pharma US Release: FDA Accepts Supplemental New Drug Application for Tarceva® (erlotinib) Tablets for Genetically Distinct Form of Advanced Lung Cancer
1/16/2013
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U.S. FDA Grants Priority Review to Boehringer Ingelheim Corporation's Afatinib NDA for EGFR Mutation-Positive Advanced NSCLC
1/15/2013
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GlaxoSmithKline (GSK) Submits Diabetes Drug to FDA
1/15/2013
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FDA Panel Backs Johnson & Johnson (JNJ)'s Risky Diabetes Drug
1/14/2013
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Teva Pharmaceutical Industries Limited (TEVA) Asks FDA Not to Approve Biogen Idec, Inc. (Massachusetts) (BIIB) MS Drugs
1/14/2013
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Idenix Pharmaceuticals, Inc. (IDIX) May Drop Delayed Hep C Drug for New Versions
1/10/2013
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GTx, Inc. (GTXI) Announces FDA's Grant of Fast Track Designation to Enobosarm for the Prevention and Treatment of Muscle Wasting in Patients With Non-Small Cell Lung Cancer
1/8/2013
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Orexigen Therapeutics, Inc. (OREX) Announces Progress With FDA on a Faster Path to Resubmission of the Contrave NDA
1/7/2013
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Keryx Biopharmaceuticals (KERX) Announces Filing of New Drug Application for Marketing Approval of Ferric Citrate (Zerenex™) in Japan by Partner, Japan Tobacco Inc.
1/7/2013
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BioSpecifics Technologies Corporation (BSTC) Announces XIAFLEX® Progress in Two Pipeline Indications
1/7/2013
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Merck & Co., Inc. (MRK) Announces FDA Acceptance of Resubmission of New Drug Application for Sugammadex Sodium Injection
1/7/2013
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Biogen Idec, Inc. (Massachusetts) (BIIB) Submitts a BLA to FDA for Hemophilia B
1/4/2013
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IGI Laboratories, Inc. Completes Filing of Two Product Development ANDAs Wiith the FDA
1/4/2013
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Merck & Co., Inc. (MRK) Resubmits Combo Cholesterol Pill to FDA
1/3/2013
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Titan Pharmaceuticals (TTP) Release: Probuphine® Receives FDA Priority Review Designation for Adult Patients With Opioid Dependence
1/2/2013
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Amarin Corporation PLC (AMRN) Announces Submission of a Supplemental New Drug Application for BASF as Additional Vascepa® Active Pharmaceutical Ingredient Supplier
1/2/2013
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Genentech (RHHBY)'s Cancer-Fighting T-DM1 Leads FDA Class of 2013
1/2/2013
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Will FDA Grant Accelerated Approval to Johnson & Johnson (JNJ) TB Drug?
12/28/2012
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AMAG Pharmaceuticals, Inc. (AMAG) Announces FDA Submission of a Supplemental New Drug Application for Feraheme
12/27/2012
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Auxilium Pharmaceuticals (AUXL) Release: FDA Accepts XIAFLEX® Supplemental Biologics License Application Filing for the Treatment of Peyronie's Disease
12/27/2012
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Cubist Pharmaceuticals, Inc. (CBST) Submits ENTEREG Supplemental NDA
12/21/2012
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Acura Pharmaceuticals, Inc. (ACUR) Submits Investigational New Drug Application
12/20/2012
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Amarin Corporation PLC (AMRN) Announces Submission of Supplemental New Drug Application for Chemport, Inc. as an Additional Vascepa® Active Pharmaceutical Ingredient Supplier
12/19/2012
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R-Tech Ueno: Announcement of Approval of sNDA for RESCULA® Ophthalmic Solution and Start of Commercialization
12/19/2012
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GlaxoSmithKline (GSK) and Theravance, Inc. (THRX) Announce Regulatory Submission for UMEC/VI (LAMA/LABA) in the U.S.
12/18/2012
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Antares Pharma, Inc. (AIS) Announces Submission of New Drug Application for OTREXUP™
12/17/2012
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Bayer HealthCare Pharmaceuticals (BAYA.F) Submits New Drug Application for Radium Ra 223 Dichloride for the Treatment of Castration-Resistant Prostate Cancer (CRPC) with Bone Metastases
12/14/2012
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FDA Accepts Takeda Pharmaceutical Co. Ltd. (TKPYY) and H. Lundbeck A/S (LUN.CO)’s Filing for Review of Brintellix (vortioxetine) for the Treatment of Major Depression
12/13/2012
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FDA Panel Rejects Zogenix, Inc. Painkiller
12/12/2012
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Janssen Research & Development Submits New Drug Application to U.S. FDA for Canagliflozin/Metformin Fixed-Dose Combination Therapy to Treat Patients with Type 2 Diabetes
12/12/2012
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Lotus Pharmaceuticals, Inc. Filed Its Abbreviated New Drug Application (ANDA) Containing a Paragraph IV Certification for a Generic Version of Xenical(R) With the U.S. Lotus Pharmaceuticals, Inc.
12/11/2012
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Eisai Inc. (ESALF.PK) Granted Additional Six Month U.S. Marketing Exclusivity for ACIPHEX® (Rabeprazole Sodium)
12/11/2012
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Janssen Biotech Inc. Submits Applications Requesting Approval of STELARA® in U.S. and Europe for Treatment of Active Psoriatic Arthritis
12/6/2012
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National Institute for Clinical Excellence (NICE) OKs Bristol Arthritis Drug After Price Cut
12/6/2012
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Zogenix, Inc. Drug May be Abused at Higher Rate, FDA Staff Says
12/5/2012
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Astellas Pharma US Announces Acceptance of U.S. New Drug Application for Tacrolimus Extended Release Capsules
12/5/2012
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Eisai Inc. (ESALF.PK) Release: FDA Accepts AcipHex® (Rabeprazole Sodium) Pediatric NDA for Priority Review
11/30/2012
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Theravance, Inc. (THRX) Halted; FDA Panel to Review VIBATIV NDA
11/30/2012
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Janssen Research & Development Release: FDA Advisory Committee Recommends Accelerated Approval of Investigational Multi-Drug Resistant Tuberculosis Treatment Bedaquiline
11/29/2012
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AVEO Oncology (Formerly known as AVEO Pharmaceuticals, Inc.) (AVEO),Astellas Pharma Inc. (YPH.BE) Receive FDA Acceptance for NDA Filing for Tivozanib
11/29/2012
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Forest Laboratories, Inc. (FRX) Files Schizophrenia Drug With FDA
11/28/2012
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Theravance, Inc. (THRX) Announces Posting of Briefing Documents for FDA Anti-Infective Drugs Advisory Committee Meeting on VIBATIV® (telavancin)
11/27/2012
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FDA Says Johnson & Johnson (JNJ)'s TB Drug Appears Safe
11/27/2012
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MAP Pharmaceuticals, Inc. (MAPP) Announces FDA Acceptance for Filing of NDA Resubmission for LEVADEX®
11/26/2012
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Ipsen (IPN.PA) and Inspiration Biopharmaceuticals Announce That OBI-1 Has Received Fast Track Designation From FDA for Acquired Hemophilia A
11/20/2012
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Astellas Pharma US Submits Supplemental New Drug Application to FDA for Tarceva® as a First-Line Therapy in Genetically Distinct Form of Non-Small Cell Lung Cancer
11/20/2012
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Sanofi (France) (SAN.PA) Diabetes Drug Wins EU Panel Recommendation
11/20/2012
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KemPharm, Inc. Receives Positive Feedback From FDA on KP201 Clinical Plan
11/20/2012
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FDA Accepts Orexo AB Zubsolv New Drug Application
11/19/2012
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Dynavax Technologies Corporation (DVAX) Falls After Vaccine Fails to Win Panel Backing
11/19/2012
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FDA Accepts Noven Pharmaceuticals Inc.s NDA for an Investigational Nonhormonal Therapy for Menopausal Vasomotor Symptoms
11/13/2012
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FDA Accepts GeNO LLC Filing of New Drug Application for GeNOsyl™ MVG-2000 Nitric Oxide Delivery System
11/13/2012
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Orexo AB Announces Submission of a New Drug Application for KW-2246 (Abstral®) in Japan
11/13/2012
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RedHill Biopharma Ltd. Announces Successful Pre-NDA Meeting Wth FDA Toward a Filing of a U.S. New Drug Application (NDA) for its RHB-103 Anti-Migraine Oral Thin-Film
11/9/2012
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FDA Panel Backs Novo Nordisk A/S (NVO) Diabetes Drugs
11/9/2012
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Merck & Co., Inc. (MRK)'s Recipe for Zzzzs in FDA's Hands Now
11/9/2012
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Zogenix, Inc. Announces FDA Advisory Committee Review of Zohydro™ ER for the Management of Chronic Pain
11/8/2012
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BioSpecifics Technologies Corporation (BSTC) Announces Submission of Supplemental Biologics License Application to FDA for XIAFLEX® for Treatment of Peyronie's Disease
11/8/2012
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Merck & Co., Inc. (MRK) Announces FDA Acceptance of New Drug Application for Suvorexant, an Investigational Insomnia Medicine
11/8/2012
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Roche (RHHBY)'s Genentech (RHHBY) Gets Priority Review for Herceptin Successor
11/8/2012
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FDA Panel Gives Unanimous OK to Novartis AG (NVS)'s Cushing's Drug
11/8/2012
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Novo Nordisk A/S (NVO)'s Insulin Tresiba Has Heart Safety Risks, FDA Says
11/6/2012
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FDA Denies Cornerstone Therapeutics Inc.'s Lixivaptan; Requests More Info
11/2/2012
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Navidea Biopharmaceuticals (NEOP) Resubmits New Drug Application for Lymphoseek® to FDA
10/31/2012
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Sunovion Pharmaceuticals Inc. Announces FDA Acceptance of 2 sNDAs for Latuda® as Monotherapy and Adjunctive Therapy in Adult Patients With Depressive Episodes Associated with Bipolar I Disorder
10/30/2012
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Bayer HealthCare Pharmaceuticals (BAYA.F)'s Stivarga® (Regorafenib) Tablets New Drug Application Granted Priority Review by U.S. FDA for the Treatment of Patients with Gastrointestinal Stromal Tumors
10/29/2012
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Titan Pharmaceuticals (TTP) Announces Submission of New Drug Application for Probuphine for the Treatment of Opioid Dependence
10/29/2012
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Novo Nordisk A/S (NVO) Shares Drop on U.S. Scrutiny of Insulin Drug
10/29/2012
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Watson Pharmaceuticals, Inc. (WPI) Confirms FDA Denies Appeal Related to Prochieve NDA
10/26/2012
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FDAAdvisoryCommittee.com Rejects United Therapeutics Corporation (UTHR) Lung Drug
10/25/2012
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Ariad Pharmaceuticals, Inc. (ARIA) Announces FDA Acceptance of NDA Filing for Ponatinib
10/24/2012
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Ferring Pharmaceuticals Announces FDA Acceptance of NDA Filing for Controlled Release Misoprostol Vaginal Insert for Decreasing Time to Vaginal Delivery in Women
10/23/2012
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Orexigen Therapeutics, Inc. (OREX) Receives Dispute Response Indicating FDA is Highly Supportive of Exploration of a Faster Path to Resubmission of the Contrave NDA
10/23/2012
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Hemispherx Biopharma (HEB) Announces FDA Confirms Advisory Committee Meeting on December 20, 2012
10/22/2012
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Orexigen Therapeutics, Inc. (OREX) Receives Dispute Response Indicating FDA is Highly Supportive of Exploration of a Faster Path to Resubmission of the Contrave NDA
10/22/2012
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FDA Panel Backs Sanofi (France) (SAN.PA) and Isis Pharmaceuticals, Inc. (ISIS) Drug for Rare Genetic Disorder
10/22/2012
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Flamel Technologies (FLML) Announces FDA Acceptance of New Drug Application
10/19/2012
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Novo Nordisk A/S (NVO) Wins EU Panel's Recommendation for Tresiba
10/19/2012
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Sanofi Pasteur (SASY.PA) Announces Application for New Four-Strain Influenza Vaccine Accepted by FDA for Review
10/18/2012
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NASDAQ Halts Trading of Aegerion Pharmaceuticals, Inc. (AEGR)'s Stock as FDA Reviews Drug
10/17/2012
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Perrigo Company (PRGO) Confirms FDA Tentative Approval for OTC Version of Omeprazole and Sodium Bicarbonate Capsules
10/17/2012
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FDA Panel Backs NPS Pharmaceuticals, Inc. (NPSP)'s Drug for Short Bowel Syndrome
10/17/2012
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FDA: Genzyme Corporation (GENZ), Isis Pharmaceuticals, Inc. (ISIS) Drug Mipomersen Cuts Cholesterol but Impacts Liver
10/17/2012
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NPS Pharmaceuticals, Inc. (NPSP) Shares Halted as FDA Panel Reviews Bowel Drug
10/16/2012
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MAP Pharmaceuticals, Inc. (MAPP) Resubmits New Drug Application to FDA for LEVADEX® Orally Inhaled Migraine Drug
10/16/2012
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Depomed, Inc. (DEPO) Announces Serada® NDA Acceptance and FDA Advisory Committee Meeting
10/15/2012
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FDA Staff: NPS Pharmaceuticals, Inc. (NPSP)'s Bowel Drug Needs No Safety Restrictions
10/15/2012
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Toddlers Facing Heart Attacks Await Ruling on New Drugs From Aegerion Pharmaceuticals, Inc. and Isis Pharmaceuticals, Inc. (ISIS)
10/8/2012
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Boston Therapeutics, Inc. Wins FDA Approval to File an Abbreviated New Drug Application for PAZAMET™ to Treat Diabetes
10/4/2012
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Orexo AB Announces Decision to Explore Strategic Alternatives for Commercialization in the U.S.
10/4/2012
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Takeda Global Research & Development Center, Inc. Progressing Well in Asia With New Drug Applications (NDA)
10/4/2012
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Shionogi, Inc.-ViiV Healthcare to File HIV Drug dolutegravir for Approval
10/4/2012
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Medicure Inc. (MCU) Announces Intention to Seek Expanded Aggrastat Label
10/2/2012
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Lundbeck Inc. (LUN.CO), Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Seek U.S. Approval for Antidepressant
10/2/2012
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Hemispherx Biopharma (HEB) Files for Treatment Expansion in Argentina for Alferon N Injection® for Hepatitis C
10/1/2012
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A.P. Pharma, Inc. (APPA) Resubmits New Drug Application for APF530, a Product Candidate for the Prevention of Chemotherapy-Induced Nausea and Vomiting
9/28/2012
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Ariad Pharmaceuticals, Inc. (ARIA) Completes Rolling Submission of New Drug Application for Ponatinib to the FDA
9/28/2012
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AVEO Oncology (Formerly known as AVEO Pharmaceuticals, Inc.) (AVEO) and Astellas Pharma Inc. (YPH.BE) Announce Submission of New Drug Application for Tivozanib for the Treatment of Advanced Renal Cell Carcinoma
9/28/2012
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Hemispherx Biopharma (HEB)'s Ampligen Rehash Unlikely to Impress FDA
9/27/2012
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Bristol-Myers Squibb Company (BMY), Pfizer Inc. (PFE) Snags FDA Decision Date for Anti-Clotting Drug
9/27/2012
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FDA Grants Priority Review Status to Sucampo Pharmaceuticals, Inc.'s AMITIZA® (lubiprostone) Submission Seeking Approval for Treatment of Opioid-induced Constipation
9/26/2012
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AEterna Zentaris (AEZS) Provides Update on NDA Filing for AEZS-130 as Diagnostic Test for Adult Growth Hormone Deficiency
9/26/2012
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Navidea Biopharmaceuticals (NEOP) Posts Lymphoseek® NDA Update to Company Website
9/25/2012
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Orexo AB Provides Update on Simplified Market Situation for Zubsolv™ (OX219) in United States
9/25/2012
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