FDA Extends NDA Review for Neuromed Pharmaceuticals's Exalgo(TM) Extended-Release Tablets
11/20/2009
More...
|
FDA Panel Rejects Protein Sciences Corporation's Cell Culture Flu Vaccine, Wants More Safety Data
11/20/2009
More...
|
Covidien (COV) Says FDA Extends Review of Opiod Pain Drug
11/20/2009
More...
|
FDA Advisory Committee Finds Data Support the Claim That Pfizer Inc. (PFE)'s (JOBS) SPIRIVA(R) HandiHaler(R) Reduces COPD Exacerbations
11/20/2009
More...
|
EU Panel Blocks Merck KGaA (MKGAF.PK)'s (JOBS) Erbitux in Lung Cancer
11/20/2009
More...
|
Merck & Co., Inc. (MRK) (JOBS) Receives CHMP Positive Opinion for New Fertility Treatment, ELONVA(R)
11/20/2009
More...
|
Dendreon Corporation (DNDN) (JOBS) Receives FDA Acknowledgement of Complete Response, PDUFA Date Assigned as May 1, 2010
11/20/2009
More...
|
U.S. FDA Panel Rejects FDA and Genentech (South SF) (DNA)'s (JOBS) Xolair Asthma Drug for Children
11/19/2009
More...
|
AstraZeneca PLC (AZN) (JOBS) Asks for U.S. Approval of Brilinta
11/19/2009
More...
|
Astellas Pharma Inc. and XenoPort, Inc. (XNPT) Announce Submission of a New Drug Application in Japan Requesting PMDA Approval of ASP8825/XP13512 for Restless Legs Syndrome
11/19/2009
More...
|
FDA Advisory Committee Finds Data Support the Safety and Effectiveness of Pfizer Inc. (PFE)'s (JOBS) Prevnar 13 Vaccine for the Prevention of Invasive Pneumococcal Disease in Infants and Young Children
11/19/2009
More...
|
FDA to Review Actelion Ltd. (ALIOF.PK)'s (JOBS) Zavesca for Additional Use
11/19/2009
More...
|
Genentech (South SF) (DNA) (JOBS) and Biogen Idec, Inc. (Massachusetts) (BIIB) (JOBS) Receive a Complete Response from the FDA for Rituxan for Chronic Lymphocytic Leukemia
11/19/2009
More...
|
Genzyme Corporation (GENZ)'s Pompe Drug Rejected--New Production Woes
11/19/2009
More...
|
NicOx SA (NCOX.F) Announces FDA Accepts Naproxcinod NDA For Filing
11/18/2009
More...
|
Roche Holding AG (RHHBF.PK) (JOBS), Genentech (South SF) (DNA) (JOBS) Apply for Avastin Advanced Breast Cancer Use
11/17/2009
More...
|
ARCA biopharma Announces Corporate and Gencaro(TM) Development Update
11/17/2009
More...
|
Genentech (South SF) (DNA) Submits Supplemental Applications to FDA for Avastin Combined with Commonly Used Chemotherapies for Women with Advanced Breast Cancer
11/17/2009
More...
|
Alkermes (ALKS) to Seek FDA Approval of Anti-Addiction Drug
11/17/2009
More...
|
Human Genome Sciences, Inc. (HGSI)'s (JOBS) Anthrax Drug Denied Approval
11/17/2009
More...
|
FDA Discusses Neuromed NDA Application for Covidien (COV)'s Exalgo
11/16/2009
More...
|
CombinatoRx, Incorporated (CRXX) And Neuromed Pharmaceuticals Receive FDA Feedback on New Drug Application for Exalgo Extended-Release Tablets
11/16/2009
More...
|
Cadence Pharmaceuticals, Inc. Announces FDA Extends New Drug Application Review for Intravenous Acetaminophen; PDUFA Goal Date Extended by Three Months
11/13/2009
More...
|
ChemGenex Pharmaceuticals Limited (CXS.AX) Announces FDA Accepts NDA for Omapro(TM) (Omacetaxine Mepesuccinate) and Grants the Filing Priority Review Status
11/11/2009
More...
|
EpiCept Corporation (EPCT) Announces Health Canada Accepts Ceplene(R) Application for Review
11/9/2009
More...
|
FDA Won't Accept Merck & Co., Inc. (MRK)'s (JOBS) Application for New Drug
11/6/2009
More...
|
FDA Grants Priority Review for Shire plc's (JOBS) Velaglucerase Alfa for Type 1 Gaucher Disease; PDUFA Date is February 28, 2010
11/4/2009
More...
|
InterMune, Inc. (ITMN) Announces Submission of NDA for Pirfenidone for the Treatment of Patients with IPF
11/4/2009
More...
|
Hemispherx Biopharma (HEB) Responding to FDA's Ampligen Questions
11/4/2009
More...
|
FDA Denies Approval for GTx, Inc. (GTXI) Drug; Seeks Additional Study
11/3/2009
More...
|
Dendreon Corporation (DNDN) Completes Submission of Biologics License Application for PROVENGE
11/3/2009
More...
|
MEDA: Retigabine Filings Completed in the US and Europe
11/2/2009
More...
|
Hemispherx Biopharma (HEB) Updates Chronic Fatigue Syndrome (CFS) Treatment and Commercial Application Programs
11/2/2009
More...
|
Transcept Pharmaceuticals, Inc. (TSPT) Sleep Drug Denied Approval, Stock Down 48.6% at Market Close
10/30/2009
More...
|
AstraZeneca PLC (AZN) (JOBS) Pulls Submissions for Lung Cancer Drug
10/30/2009
More...
|
Zogenix, Inc. and Desitin Pharmaceuticals GmbH Announce Filing for European Regulatory Approval of SUMAVEL(TM) DosePro(TM) - European Pivotal Trial Confirms Bioequivalence
10/28/2009
More...
|
Regeneron Pharmaceuticals, Inc. (REGN)'s Rilonacept Granted European Marketing Authorization for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)
10/28/2009
More...
|
Lifeline BioTechnologies, Inc. (LBTN.PK) Reports on FDA Filing Status
10/26/2009
More...
|
Cephalon, Inc. (CEPH) Notified of Generic Filing for Armodafinil Tablets
10/22/2009
More...
|
FDA Declines to Approve King Pharmaceuticals®, Inc.'s Heart Imaging Drug
10/22/2009
More...
|
Shire plc Targets Fourth Quarter Filing of BLA for REPLAGAL(R) for Fabry Disease With U.S. FDA Early Access for Fabry Patients Available Under Treatment Protocol and Emergency IND
10/21/2009
More...
|
FDA Delays Endo Pharmaceuticals (ENDP)'s Testosterone Gel Approval
10/21/2009
More...
|
ADVENTRX Pharmaceuticals Inc. (ANX) Provides Business Update Following Recent Financing Activity NDA Submission for ANX-530 on Track
10/20/2009
More...
|
US FDA Delays Approval of Amgen (AMGN) (JOBS) Osteoporosis Drug
10/20/2009
More...
|
Genentech (South SF) (DNA) And Biogen Idec, Inc. (Massachusetts) (BIIB) Receive a Complete Response from FDA for Earlier Use of Rituxan for Rheumatoid Arthritis
10/20/2009
More...
|
Human Genome Sciences, Inc. (HGSI) to Seek Hepatitis Drug Approval in Q4
10/19/2009
More...
|
US Seeks More Information on Novartis AG (JOBS) Lung Drug
10/19/2009
More...
|
Amgen (AMGN)'s (JOBS) Bone Drug May Face Delays In FDA Decision
10/16/2009
More...
|
Questcor Pharmaceuticals, Inc. (Headquarters) (QSC) Resubmits Supplemental New Drug Application to FDA for H.P. Acthar(R) Gel for Treatment of Infantile Spasms
10/16/2009
More...
|
Acorda Therapeutics (ACOR) (JOBS) Announces Positive Vote by FDA Advisory Committee for Fampridine-SR
10/15/2009
More...
|
Acorda Therapeutics (ACOR) (JOBS) Stock Trading Halted Today; FDA Advisory Committee to Review Fampridine-SR for Improvement of Walking Ability in People with Multiple Sclerosis
10/14/2009
More...
|
Perrigo Company (PRGO) Confirms Filing for Generic Version of Men's Rogaine(R) Foam
10/13/2009
More...
|
Fibrocell Science, Inc. Reports Outcome of FDA Advisory Committee Meeting on Azfibrocel-T for Wrinkles
10/12/2009
More...
|
US FDA Panel Backs Wider Use of Pfizer Inc. (PFE) (JOBS) HIV Drug
10/9/2009
More...
|
US FDA Staff Says Limited Effect with Acorda Therapeutics (ACOR) (JOBS) MS Drug
10/9/2009
More...
|
CardioPharma Prepares for FDA Submission World's First Patented Triple-Combination CardiaPill(R)
10/9/2009
More...
|
FDA Declines To Approve New Indication For Spectrum Pharmaceuticals, Inc. (SPPI) (JOBS) Fusilev; Shares Plunge
10/9/2009
More...
|
FDA Fails to Approve Genzyme Corporation (GENZ)'s Clolar in Adults with AML
10/8/2009
More...
|
GlaxoSmithKline (GSK) (JOBS) Receives Unanimous FDA Panel Approval Recommendation for VOTRIENT(TM)
10/7/2009
More...
|
Genzyme Corporation (GENZ) Receives FDA Complete Response Letter for Clolar
10/6/2009
More...
|
FDA Advisory Committee Recommends Approval of Schering-Plough Corporation (SGP)'s (JOBS) PEGINTRON(R) for the Adjuvant Treatment of Stage III Malignant Melanoma
10/5/2009
More...
|
EU Agency Recommends Baxter International, Inc. (BAX)'s (JOBS) H1N1 Flu Shot
10/2/2009
More...
|
US FDA Staff Questions GlaxoSmithKline (GSK) (JOBS) Kidney Cancer Drug
10/2/2009
More...
|
FDA Finds "Subtantial" Toxicity with Schering-Plough Corporation (SGP)'s (JOBS) PegIntron Use
10/1/2009
More...
|
Discovery Laboratories (DSCO) Says FDA Agrees on Lung Drug Program
9/30/2009
More...
|
Sosei Group Corporation Announces Filing of NDA for SOH-075 (NorLevo(R)) in Japan
9/30/2009
More...
|
Labopharm (DDS.TO) Receives Notice of ANDA Submission with Paragraph IV Certification for Generic of Ryzolt(TM)
9/30/2009
More...
|
EMD Serono, Inc. Submits Application for Cladribine Tablets as a Potential Oral Short-Course Multiple Sclerosis Therapy in the United State
9/30/2009
More...
|
Merck KGaA (MKGAF.PK) Seeks FDA Approval for First MS Pill
9/30/2009
More...
|
Abbott Laboratories (ABT) and Eisai Company, Ltd. (ESALY.PK) Submit Application for Approval of Humira(R) for the Treatment of Crohn's Disease in Japan
9/30/2009
More...
|
Cell Therapeutics, Inc. (CTIC) Applies for European Orphan Drug Designation for Pixantrone in Aggressive Non-Hodgkin's Lymphoma (NHL)
9/29/2009
More...
|
Eisai Company, Ltd. (ESALY.PK) Submits Application for Additional Indication of its Proton Pump Inhibitor PARIET(R) for Non-erosive GERD in Japan
9/29/2009
More...
|
Sanofi-Aventis (France) (SASY.PA)'s Multaq(R) Recommended for Approval in the European Union
9/28/2009
More...
|
Merck Sharp & Dohme (MRK) Receives Positive CHMP Opinion for 'Januvia(R)' and 'Janumet(R)' as Add-On to Insulin in the European Union
9/28/2009
More...
|
Sciele Pharma, Inc. (SCRX) Submits New Drug Application to FDA for Glycopyrrolate Oral Solution, a Treatment for Chronic, Moderate-to-Severe Drooling in Pediatric Patients
9/28/2009
More...
|
NicOx SA (NCOX.F) Submits New Drug Application (NDA) for Naproxcinod to the US FDA
9/25/2009
More...
|
Wyeth (WYE) Wins EU Recommendation for Prevenar 13
9/25/2009
More...
|
Sanofi-Aventis (France) (SASY.PA): Multaq(R) (dronedarone) Recommended for Approval in the European Union
9/25/2009
More...
|
Cephalon, Inc. (CEPH) Sleep Drug Wins Fast Review for Jet Lag
9/25/2009
More...
|
Dendreon Corporation (DNDN) Reports PROVENGE Regulatory and Commercialization Progress and Future Pipeline Plans at Analyst Event
9/25/2009
More...
|
CombinatoRx, Incorporated (CRXX) Stock Trading Halted Today; FDA Advisory Committees Meet to Discuss Exalgo
9/24/2009
More...
|
Novo Nordisk A/S (NVO) Says FDA Feedback on Victoza Delayed
9/23/2009
More...
|
FDA Grants Priority Review Status to Supplement Containing Long-Term Survival Data for VELCADE(R) (bortezomib) for Injection
9/18/2009
More...
|
Sanofi-Aventis (France) (SASY.PA) Receives Complete Response Letter from the FDA for Eplivanserin (Ciltyri(R)) Submission; Additional Information Requested
9/17/2009
More...
|
FDA Advisory Committee Unanimously Recommends Approval of BioSpecifics Technologies Corporation (BSTC)'s XIAFLEX(TM) for Treatment of Dupuytren's Disease
9/17/2009
More...
|
FDA Panel Backs Auxilium Pharmaceuticals (AUXL) Hand Disorder Drug
9/17/2009
More...
|
Mylan Inc. (MYL)'s Matrix Receives Tentative FDA Approval Under PEPFAR for Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets
9/16/2009
More...
|
Savient Pharmaceuticals, Inc. (SVNT): FDA Does Not See More Trials for Gout Drug
9/16/2009
More...
|
FDA Staff Weighs Auxilium Pharmaceuticals (AUXL) Hand Disorder Drug; Xiaflex Effective, Side Effects Minor
9/16/2009
More...
|
BioSpecifics Technologies Corporation (BSTC) Stock Trading Halted Today; FDA Advisory Committee to Review XIAFLEX(TM) BLA for Dupuytren's Disease
9/16/2009
More...
|
Cell Therapeutics, Inc. (CTIC) Advances Pixantrone Filing Process in Europe; Submits Pediatric Investigation Plan (PIP)
9/15/2009
More...
|
FDA Rejects Use Of Zeltia SA, Johnson & Johnson (JNJ) Drug Combo
9/14/2009
More...
|
U.S. FDA to Review Mylan Inc. (MYL)'s Generic Copaxone
9/14/2009
More...
|
Discovery Laboratories (DSCO) to Meet FDA to Review Lung Drug Options
9/11/2009
More...
|
FDA Issues Complete Response Letter For Centocor Ortho Biotech Products, L.P.'s Trabectedin Combined With DOXIL; Agency Requests Additional Information
9/11/2009
More...
|
FDA Advisory Committee Recommends Approval for Use of Merck & Co., Inc. (MRK)'s (JOBS) GARDASIL(R) in Boys and Men
9/10/2009
More...
|
FDA Committee Recommends Approval of GlaxoSmithKline (GSK) (JOBS) Cervical Cancer Vaccine Cervarix
9/10/2009
More...
|
ChemGenex Pharmaceuticals Limited (CXS.AX) Submits New Drug Application for OMAPRO(TM) (Omacetaxine Mepesuccinate) to U.S. FDA
9/9/2009
More...
|
UK's NICE Again Rejects Bayer Corporation (BAY) (JOBS) Liver Cancer Drug
9/9/2009
More...
|
FDA Sets Action Date of April 23, 2010 for Review of Cell Therapeutics, Inc. (CTIC)'s Pixantrone NDA
9/8/2009
More...
|
Acura Pharmaceuticals, Inc., King Pharmaceuticals®, Inc. Say No New Trials Required for Pain Drug Now
9/4/2009
More...
|
Bristol-Myers Squibb Company (BMY) Announces Acceptance of Submission for Belatacept Biologic License Application
9/4/2009
More...
|
The Medicines Company (MDCO) Receives Paragraph IV Notifications
9/4/2009
More...
|
China Sky One Medical, Inc. Submits Application to Perform Clinical Trials for Two New Eye Drugs to SFDA
9/3/2009
More...
|
Endo Pharmaceuticals (ENDP) Says FDA Extends Review Date for Testosterone Treatment
9/3/2009
More...
|
China Aoxing Pharmaceutical Corp. (CAXG) Announces Submission of NDA of Its Leading Narcotic Drug for the Treatment of Acute Moderate to Severe Cough
9/3/2009
More...
|
FDA Advisory Committee Recommends Gloucester Pharmaceuticals, Inc.'s Romidepsin for Approval for Cutaneous T-cell Lymphoma
9/3/2009
More...
|
FDA to Review Supplement Containing Long-Term Survival Data For VELCADE(R) (bortezomib) For Injection
9/2/2009
More...
|
Sinovac Biotech Ltd. (SNVBF): China Set to Approve 1-Dose Swine Flu Vaccines
9/2/2009
More...
|
Gloucester Pharmaceuticals, Inc. Gears Up for FDA Panel Vote on Lymphoma Drug
9/2/2009
More...
|
Vion Pharmaceuticals (VION) Announces Results of the Oncologic Drugs Advisory Committee
9/2/2009
More...
|
SkyePharma Inc. (SKYE) Says More Tests Needed for Asthma Drug
9/2/2009
More...
|
Johnson & Johnson (JNJ), Basilea Pharmaceutica Respond to FDA Antibiotic Concerns
9/1/2009
More...
|
US FDA Staff Question Genzyme Corporation (GENZ) (JOBS) Leukemia Drug Study
8/31/2009
More...
|
Pozen, Inc. (POZN) Announces FDA Acceptance of NDA For VIMOVO(TM)
8/31/2009
More...
|
Takeda Pharmaceutical Co. Ltd. (TKDG.DE) (JOBS) to Start Key Diabetes Drug Trial in September
8/28/2009
More...
|
New PDUFA Action Date Assigned for Labopharm (DDS.TO) Drug; FDA Could Rule in February
8/26/2009
More...
|
Schering-Plough Corporation (SGP) Announces Two European Filings
8/26/2009
More...
|
Acorda Therapeutics (ACOR) Reports Date of FDA Advisory Committee Review of Fampridine-SR for Improvement of Walking Ability in People with MS
8/25/2009
More...
|
Salix Pharmaceuticals, Ltd. (SLXP) Announces FDA Acceptance for Filing and Priority Review Designation For Rifaximin NDA For the Maintenance of Remission of Hepatic Encephalopathy
8/25/2009
More...
|
FDA Agrees to Review Cell Therapeutics, Inc. (CTIC) Application
8/25/2009
More...
|
The Medicines Company (MDCO) (JOBS) Withdraws European Application for Drug
8/24/2009
More...
|
FDA Delays Action on Johnson & Johnson (JNJ) (JOBS) Seizure Drug
8/24/2009
More...
|
Stemedica Cell Technologies, Inc. Requests Pre-IND Meeting With FDA
8/21/2009
More...
|
FDA Accepts Par Pharmaceutical Companies, Inc. (PRX) Drug Application for Miconazole Lauriad(R) to Treat Oropharyngeal Candidiasis
8/19/2009
More...
|
BioAlliance Pharma: FDA Accepts New Drug Application for Miconazole Lauriad(R) (Loramyc(R)) to Treat Oropharyngeal Candidiasis
8/19/2009
More...
|
Geron Corporation (GERN)'s (JOBS) Spinal Injury Drug Application on Clinical Hold
8/18/2009
More...
|
Hospira, Inc. (HSP) Says FDA Suspends Oxaliplatin Approval
8/18/2009
More...
|
Mylan Inc. (MYL)'s Matrix Receives First and Only Tentative FDA Approval Under PEPFAR for Generic Version of Atripla(R) HIV Treatment
8/18/2009
More...
|
US FDA to Seek Panel's Advice on Q-Med AB's Studies
8/17/2009
More...
|
Gloucester Pharmaceuticals, Inc. Announces FDA Advisory Committee Meeting to Discuss Romidepsin New Drug Application
8/17/2009
More...
|
A Partial Approval for Amgen (AMGN)'s (JOBS) Osteoporosis Drug
8/17/2009
More...
|
Pharming Group (PHGUF.PK): FDA Approves Investigational New Drug application for Prodarsan(R) in Cockayne Syndrome patients
8/14/2009
More...
|
Amgen (AMGN) (JOBS) to Discuss Denosumab Data at Today's Advisory Committee for Reproductive Health Drugs
8/13/2009
More...
|
Wyeth (WYE) (JOBS) Says FDA Extends Prevnar 13 Review by 3 Months
8/13/2009
More...
|
Amgen (AMGN)'s (JOBS) Bone-Density Treatment Gets NEJM Nod and FDA Scrutiny
8/13/2009
More...
|
Theratechnologies Inc. (TH.TO) to Receive a Milestone Payment of US $10 Million Associated With the FDA Acceptance to File Tesamorelin NDA
8/12/2009
More...
|
FDA Advisory Committee Recommends GE Healthcare's (JOBS) DaTSCAN (Ioflupane I 123 Injection)
8/12/2009
More...
|
Labopharm (DDS.TO) Submits Response to FDA for Novel Antidepressant
8/11/2009
More...
|
SemBioSys Genetics Inc. (SBS.TO) Completes Pre-IND Meeting With U.S. FDA For APO AI(milano)
8/11/2009
More...
|
US FDA Review of Amgen (AMGN) (JOBS) Bone Drug to Focus on Safety
8/11/2009
More...
|
Sepracor, Inc. (SEPR) Announces New Drug Submission (NDS) to Health Canada for STEDESA(TM) as Adjunctive Treatment for Epilepsy
8/10/2009
More...
|
Allos Therapeutics, Inc. (ALTH) Announces FDA Advisory Committee to Review Pralatrexate for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma
8/10/2009
More...
|
Vion Pharmaceuticals (VION) Announces Oncologic Drugs Advisory Committee Meeting for Onrigin(TM)
8/10/2009
More...
|
Sanofi Pasteur (SASY.PA) Submits Supplemental Application for A(H1N1) Pandemic Vaccine to U.S. FDA
8/7/2009
More...
|
Orexo AB: Abstral(TM) File Submitted to the FDA for Approval in the USA
8/6/2009
More...
|
Acura Pharmaceuticals, Inc. Submits Acurox(R) Briefing Package to FDA
8/6/2009
More...
|
EpiCept Corporation (EPCT) Announces Filing of New Drug Submission for Approval of Ceplene in Canada
8/5/2009
More...
|
ADVENTRX Pharmaceuticals Inc. (ANX) Narrows Prior Guidance on NDA Submission Timeline
8/5/2009
More...
|
US Panel Backs Plan for ViroPharma Incorporated (VPHM) (JOBS) Drug Copies
8/5/2009
More...
|
Novavax, Inc. (NVAX) Says Can Ready H1N1 Vaccine Within 11 Weeks
8/5/2009
More...
|
Labopharm (DDS.TO) Files New Drug Submission with Health Canada for Novel Antidepressant
8/5/2009
More...
|
FDA Extends Review of Nuvo Research Inc. (NRI.TO)'s Pennsaid(R) Diclofenac Sodium Topical Solution
8/5/2009
More...
|
DOR BioPharma, Inc. (DORB) Receives FDA Orphan Drug Designation for orBec(R) for the Treatment of Chronic Gastrointestinal GVHD
8/4/2009
More...
|
Kamada Ltd.'s Biologics License Application for IV-AAT to Treat Alpha-1 Antitrypsin Deficiency is Accepted for Review by the US FDA
8/4/2009
More...
|
New Delivery System for RELISTOR in Pre-Filled Syringes Submitted for U.S. and European Marketing Approval By Progenics Pharmaceuticals, Inc. (PGNX) And Wyeth (WYE)
8/4/2009
More...
|
Savient Pharmaceuticals, Inc. (SVNT) Says FDA Does Not Approve Gout Drug; to Resubmit
8/4/2009
More...
|
XenoPort, Inc. (XNPT) Announces Astellas Pharma Inc. Plans to File an NDA for XP13512 in Japan
8/4/2009
More...
|
XenoPort, Inc. (XNPT) Announces Astellas Pharma Inc.'s Plans to File an NDA for XP13512 in Japan
8/3/2009
More...
|
U.S. FDA's Arthritis Advisory Committee Confirms Date to Review Auxilium Pharmaceuticals (AUXL)'s XIAFLEX(TM) for the Treatment of Dupuytren's Contracture
8/3/2009
More...
|
AstraZeneca PLC (AZN) (JOBS) Still Awaiting FDA News on Onglyza
8/3/2009
More...
|
Schering-Plough Corporation (SGP) (JOBS) Release: FDA Advisory Committee Votes in Favor of SAPHRIS(R) (asenapine) for Acute Bipolar I Disorder and Acute Schizophrenia
7/31/2009
More...
|
AstraZeneca PLC (AZN) Submits New Drug Applications for ZACTIMA(TM) in Second-Line Advanced Non-Small Cell Lung Cancer
7/30/2009
More...
|
Watchdog Delays UK Debut Of AstraZeneca PLC (AZN) (JOBS) Swine Flu Treatment
7/30/2009
More...
|
FDA Panel Rejects King Pharmaceuticals®, Inc. Imaging Drug Data
7/30/2009
More...
|
GlaxoSmithKline (GSK) (JOBS) Pulls EU Application For Rare Disease Drug
7/30/2009
More...
|
BioAlliance Pharma Submits Clinical Trial New Drug Application And Announces Results Of Its July 27th 2009 General Assembly Meeting
7/29/2009
More...
|
Novartis Pharma AG (NVS) (JOBS) Obtains EU Positive Opinion For New Biologic Drug
7/29/2009
More...
|
FDA Delays Intuniv But Shire plc Still Sees Q4 Launch
7/28/2009
More...
|
US FDA Staff--Schering-Plough Corporation (SGP) (JOBS) Antipsychotic Works
7/28/2009
More...
|
Merck KGaA (MKGAF.PK) Falls; EU Rejects Erbitux for Lung Cancer
7/27/2009
More...
|
Mesoblast Limited Applies For Regulatory Approval Of Its Bone Fracture Repair Products
7/23/2009
More...
|
Schering-Plough Corporation (SGP) Announces U.S. Filing of Mometasone Furoate/Formoterol Fumarate Combination for the Maintenance Treatment of Asthma
7/23/2009
More...
|
FDA Extends Takeda Pharmaceutical Co. Ltd. (TKDG.DE)'s (JOBS) Alogliptin-Actos Drug Review
7/23/2009
More...
|
BioAlliance Pharma: Turnover for Q2 2009: Sustained Sales Growth and an NDA for Loramyc(R) in the USA
7/22/2009
More...
|
FDA Rejects Labopharm (DDS.TO)'s Once-Daily Depression Drug
7/21/2009
More...
|
Nycomed Announces FDA Filing for Daxas(R) in COPD
7/20/2009
More...
|
A.P. Pharma, Inc. (APPA) Announces FDA Acceptance of APF530 New Drug Application for Chemotherapy-Induced Nausea and Vomiting
7/20/2009
More...
|
Cornerstone Therapeutics Inc. Submits Regulatory Filing for Extended-Release Antitussive Product
7/16/2009
More...
|
FDA Accepts Tris Pharma, Inc.'s ANDA with Paragraph IV Certification for a Generic Equivalent to Delsym
7/16/2009
More...
|
Cadence Pharmaceuticals, Inc. Says Pain Drug Gets Priority Review Status
7/16/2009
More...
|
Watson Pharmaceuticals, Inc. (WPI) Confirms Filing of Abbreviated New Drug Application for Generic Sanctura XR(R)
7/15/2009
More...
|
Watson Pharmaceuticals, Inc. (WPI) Receives a Complete Response Letter for Its 24-Week Formulation of TRELSTAR(R) NDA; FDA Requests More Data
7/14/2009
More...
|
Protalix Biotherapeutics Holds Pre-NDA Meeting with FDA for prGCD
7/14/2009
More...
|
US FDA Staff Question Johnson & Johnson (JNJ), Zeltia Group (18494051.MA) Cancer Drug Data
7/13/2009
More...
|
Victory Pharma, Inc. Announces FDA Accepts MGX006 NDA for Review
7/13/2009
More...
|
Spectrum Pharmaceuticals, Inc. (SPPI) Submitted Formal Response to FDA Complete Response Letter on Wednesday, July 8, 2009
7/10/2009
More...
|
Alkermes (ALKS): New Drug Application for Exenatide Once Weekly Accepted for Review by FDA
7/8/2009
More...
|
Eisai Corporation of North America Release: FDA Accepts sNDA for Alternative Dosing Regimen for Dacogen(R) (decitabine for injection) to Treat Patients with Myelodysplastic Syndromes (MDS)
7/8/2009
More...
|
FDA will Review Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly and Company (LLY), and Alkermes (ALKS)' Exenatide Application
7/8/2009
More...
|
King Pharmaceuticals®, Inc., Pain Therapeutics (PTIE) May Refile Remoxy in 2010
7/7/2009
More...
|
DURECT Corporation (DRRX) REMOXY(R) NDA Update
7/7/2009
More...
|
Shire plc has Filed a Treatment Protocol for Velaglucerase Alfa for Gaucher Disease
7/7/2009
More...
|
FDA Tries to Speed Access to Protalix Biotherapeutics Gaucher Drug
7/6/2009
More...
|
Spectrum Pharmaceuticals, Inc. (SPPI) Receives Complete Response Letter from FDA for Zevalin
7/6/2009
More...
|
Novartis Corporation (NVS) Sees FDA Decision on Menveo Early 2010 US After Regulator Seeks More Data on Meningitis Vaccine
7/1/2009
More...
|
Eisai Corporation of North America and Pfizer Inc. (PFE) Decide not to Appeal NICE Decision and Call for an Expedited Review of Guidance for Alzheimer's Disease
7/1/2009
More...
|
Pozen, Inc. (POZN) Submits New Drug Application For VIMOVO(TM) (PN 400)
6/30/2009
More...
|
Cephalon, Inc. (CEPH) Submits NUVIGIL Supplemental New Drug Application for the Treatment of Excessive Sleepiness Associated with Jet Lag Disorder
6/30/2009
More...
|
PPD, Inc. (PPDI) Confirms Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Receives FDA Complete Response for Alogliptin; Takeda to Conduct More Trials
6/30/2009
More...
|