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Clinical - BLA/NDA/ANDA
Boehringer Ingelheim Pharmaceuticals, Inc. And Eli Lilly and Company (LLY) Announce New Drug Application Filing In The U.S. For The Combination Tablet Of Empagliflozin And Linagliptin 4/14/2014  More...
Bristol-Myers Squibb Company (BMY) Submits New Drug Application To FDA For A Fixed-Dose Combination Tablet Of Atazanavir Sulfate With Cobicistat For People Living With HIV-1 4/14/2014  More...
Bay Area's IMPAX Laboratories, Inc. (IPXL) Tries Again With Once-Rebuffed Parkinson's Drug Rytary 4/11/2014  More...
Janssen Research & Development Release: Supplemental New Drug Application For IMBRUVICA™ (ibrutinib) Submitted To The U.S. FDA 4/8/2014  More...
Pharmacyclics, Inc. (PCYC) Files Supplemental New Drug Application For IMBRUVICA With Phase III CLL Study Data 4/8/2014  More...
Bristol-Myers Squibb Company (BMY) Submits NDAs For Daclatasvir And Asunaprevir To The FDA For Hepatitis C Drugs 4/7/2014  More...
Gilead Sciences, Inc. (GILD)'s Ledipasvir/Sofosbuvir Fixed-Dose Combo Hep C Tablet Wins FDA Priority Review 4/7/2014  More...
TWi Pharmaceuticals, Inc.i Announces ANDA Approval Of Generic Procardia Xl® Tablets 30 Mg, 60 Mg And 90 Mg In The United States 4/7/2014  More...
Sanofi (France) (SAN.PA) Will Try Again, To Resubmit Lemtrada Application For FDA Review 4/7/2014  More...
MannKind Corporation (MNKD) Rockets As FDA Panel Backs Inhaled Diabetes Drug Afrezza; Stock Up 73.88% At Market Close (April 2, 2014) 4/4/2014  More...
Ventrus Biosciences, Inc.  (VTUS) Receives Date For Type B Pre-NDA Meeting With FDA For DOLIZEM (Diltiazem Hydrochloride Cream) In Anal Fissures 4/4/2014  More...
FDA Accepts The Filing Of The Medicines Company (MDCO)'s US Biologic License Application For Fibrocaps Hemostatic Agent 4/4/2014  More...
Helix Biopharma (CC:HBP) Submits L-DOS47 Investigational New Drug Application With FDA 4/4/2014  More...
Astellas Pharma US Announces European Regulatory Submission For XTANDI® (enzalutamide) Capsules For Chemotherapy-Naive Metastatic Prostate Cancer 4/3/2014  More...
Omeros Corporation (OMER) Release: Investigational New Drug Application Cleared By FDA For OMS721 In Thrombotic Microangiopathies 4/3/2014  More...
Immune Response BioPharma Announces FDA BLA Fee Waiver Granted Clears Path For REMUNE Approval 4/2/2014  More...
Janssen Research & Development Submits New Drug Application To FDA For A Fixed-Dose Combination Tablet Of HIV-1 Medicine Darunavir With Cobicistat As Part Of Combination HIV Therapy 4/2/2014  More...
FDA Panel Backs Durata Therapeutics, Inc.  (DRTX)'s Two New Anti-Infective Drugs 4/1/2014  More...
GlaxoSmithKline (GSK) Pulls Bid To Extend Use Of Kidney Drug To Ovarian Cancer 3/31/2014  More...
pSivida Corp (PSDV) Announces Resubmission Of New Drug Application For ILUVIEN® 3/27/2014  More...
OptiNose AS Announces FDA Acceptance Of New Drug Application For AVP-825 For The Acute Treatment Of Migraine 3/27/2014  More...
Alimera Sciences (ALIM) Announces Resubmission Of ILUVIEN® New Drug Application To FDA 3/27/2014  More...
AVANIR Pharmaceuticals (AVNR) Announces Acceptance Of New Drug Application For AVP-825 For The Acute Treatment Of Migraine 3/27/2014  More...
Novartis AG (NVS)'s Serelaxin Should Not Be Approved For Heart Failure: FDA Staff 3/26/2014  More...
Rockwell Medical (RMTI) Submits New Drug Application For Triferic™ For The Treatment Of Iron Replacement In Chronic Kidney Disease Patients On Hemodialysis 3/24/2014  More...
Elite Pharmaceuticals, Inc. (ELI) Announces Supplemental Application For Site Transfer Of Isradipine 3/24/2014  More...
Novo Nordisk A/S (NVO) Sees Chance Of U.S. Tresiba Launch Before Rival Products 3/21/2014  More...
Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company (LLY) Diabetes Drug Empagliflozin Wins EU Panel's Backing 3/21/2014  More...
EU Agency Backs New Drugs From Johnson & Johnson (JNJ), Eli Lilly and Company (LLY) And Takeda 3/21/2014  More...
Arbor Pharmaceuticals Announces FDA Acceptance For Filing Of Its Second NDA 3/20/2014  More...
NDA For Eagle Pharmaceuticals (EGRX)' Orphan Drug Ryanodex® For The Treatment Of Malignant Hyperthermia Accepted By FDA, Priority Review Granted 3/20/2014  More...
Provepharm Announces That Its Partner In Japan, Daiichi Sankyo, Inc. (4568.t) Has Filed An NDA For The Marketing Of The Methylene Blue Injection Medicinal Product In Japan, Made Out Of Proveblue® Methylene Blue Active Substance 3/19/2014  More...
Astellas Pharma Inc. (ALPMY) And Medivation, Inc. (MDVN) Submit Supplemental New Drug Application For XTANDI (Enzalutamide) For Chemotherapy-Naive Advanced Prostate Cancer 3/18/2014  More...
Sucampo Pharmaceuticals, Inc. (SCMP), Takeda Pharmaceutical Co. Ltd. (TKPYY)'s New Drug Application For AMITIZA® Dealt A Huge Setback 3/17/2014  More...
FDA Accepts Veloxis Pharmaceuticals A/S (VELO)'s New Drug Application For Envarsus® 3/14/2014  More...
IGI Laboratories, Inc. Announces First ANDA Approval 3/12/2014  More...
Hemispherx Biopharma (HEB) Announces Plans To File For Regulatory Approval Of Ampligen® To Treat Chronic Fatigue Syndrome (CFS) In Three Additional Latin America Countries 3/11/2014  More...
FDA Says OK To Review Of Lundbeck Inc. (LUN.CO)'s New Drug Application For Intravenous Carbamazepine 3/10/2014  More...
Eli Lilly and Company (LLY) Says New Drug Application Rejected On Facility Issues 3/6/2014  More...
Navidea Biopharmaceuticals (NAVB) Announces Acceptance For Review Of An Additional sNDA To Further Expand Lymphoseek® Labeling 3/5/2014  More...
Forest Laboratories, Inc. (FRX) And Adamas Pharmaceuticals Announce Forest’s Submission Of New Drug Application For Memantine Extended Release And Donepezil Fixed-Dose Combination For Alzheimer’s Disease 3/4/2014  More...
IGI Laboratories, Inc. Announces Fourteenth ANDA Submission 3/4/2014  More...
IntelGenx Corp. And RedHill Biopharma Ltd. (RDHL) Submit Response To FDA CRL For Versafilm™ Product For Migraines 3/3/2014  More...
Forest Laboratories, Inc. (FRX) Submits A New Drug Application For Nebivolol And Valsartan Combination In Hypertension 2/27/2014  More...
Biocryst Pharmaceuticals (BCRX) Announces Peramivir NDA Acceptance By The FDA 2/25/2014  More...
Regeneron Pharmaceuticals, Inc. (REGN) Announces FDA Acceptance Of EYLEA® (Aflibercept) Injection Supplemental Biologics License Application For The Treatment Of Macular Edema Following Branch Retinal Vein Occlusion 2/24/2014  More...
FDA Accepts For Review Merck & Co., Inc. (MRK)’s Biologics License Application For V503, Investigational 9-valent Human Papillomavirus Vaccine 2/20/2014  More...
Egalet Receives Fast Track Designation For Egalet-001 And Egalet-002 For Moderate To Severe Pain 2/20/2014  More...
FDA Accepts Filing Of The Medicines Company (MDCO)'s New Drug Application For Intravenous Antibiotic Oritavancin With Priority Review 2/19/2014  More...
Navidea Biopharmaceuticals (NAVB) Announces Priority Review For The sNDA To Expand Lymphoseek® Labeling For Sentinel Lymph Node Detection In Patients With Head And Neck Cancer 2/18/2014  More...
Cellceutix (CTIX) Submits Investigational New Drug Application (IND) For Clinical Trial Of New Anti-Psoriasis Drug, Enrollment Underway In Phase 2b Clinical Trials Of Brilacidin 2/18/2014  More...
FDA Rejects Wider Use Of Bayer AG (BAYN.DE)'s Xarelto Drug For Acute Coronary Syndrome 2/14/2014  More...
FDA Declines To Approve DURECT Corporation (DRRX)'s Pain Drug; Stock Drops -20.51% At Market Close (February 13, 2014) 2/14/2014  More...
FDA Staff: The Medicines Company (MDCO)'s Cangrelor Drug Should Not Be Approved 2/12/2014  More...
Gilead Sciences, Inc. (GILD) Seeks FDA OK Of Oral Attack On Hepatitis C 2/12/2014  More...
FDA Wants More Info On Sprout Pharmaceuticals's Female Libido Pill 2/11/2014  More...
Scancell: SCIB1 Granted FDA Orphan Drug Status 2/11/2014  More...
Sprout Pharmaceuticals Receives Clear Guidance From FDA On Path Forward To Resubmit New Drug Application For Flibanserin, The First Potential Medical Treatment For Hypoactive Sexual Desire Disorder In Premenopausal Women 2/10/2014  More...
Spectrum Pharmaceuticals, Inc. (SPPI) Announces FDA’s Acceptance Of NDA Filing For Beleodaq™ (Belinostat) For Injection, A Novel Pan-HDAC Inhibitor 2/6/2014  More...
Repros Therapeutics Inc. (RPRX) Meets With FDA To Discuss Data Requirements For Androxal® In The Treatment Of Secondary Hypogonadism 2/6/2014  More...
FDA Grants Acceptance To File And Priority Review For TopoTarget A/S's Beleodaq™ (Belinostat) NDA In PTCL 2/6/2014  More...
FDA Grants Fast Track Designation To Omeros Corporation (OMER) OMS824 Huntington's Disease Program 2/5/2014  More...
FDA Denies IntelGenx Corp., RedHill Biopharma Ltd. (RDHL)'s Acute Migraine Drug 2/4/2014  More...
Salix Pharmaceuticals, Ltd. (SLXP) Announces Acceptance Of NDA Filing For Budesonide Foam In Patients With Distal Ulcerative Colitis 1/30/2014  More...
FDA Panel Gives Blessing To Merck & Co., Inc. (MRK)'s Ragweed Allergy Pill 1/29/2014  More...
Thousands Of Prostate Patients Denied Astellas Pharma Inc. (ALPMY) Drug That Can Extend Life In Watchdog U-Turn 1/29/2014  More...
Medac Pharma, Inc. Secures FDA Acceptance Of A New Drug Application (NDA) For Methotrexate-Containing Autopen 1/27/2014  More...
Heron Therapeutics, Inc. (APPA) Provides Update On Sustol Resubmission 1/27/2014  More...
No Serious Side Effects With Merck & Co., Inc. (MRK)'s Experimental Allergy Pill — FDA Documents 1/27/2014  More...
ALK-Abello A/S Announces Posting Of Briefing Documents For FDA Advisory Committee Meeting On The Ragweed Sublingual Tablet 1/24/2014  More...
VIVUS, Inc. (VVUS) And Auxilium Pharmaceuticals (AUXL) Announce FDA Acceptance Of Supplemental Filing Seeking An Update Of Prescribing Information For STENDRA (Avanafil) 1/23/2014  More...
Actavis (ACT) Comments On Notification To Allergan Inc. (AGN) Of Submission Of Application For Restasis® 1/23/2014  More...
AMAG Pharmaceuticals, Inc. (AMAG) Drops As The FDA Turns Down Application For Iron Deficiency Drug Feraheme® 1/22/2014  More...
VIVUS, Inc. (VVUS) And Auxilium Pharmaceuticals (AUXL) Announce FDA Acceptance Of Supplemental Filing Seeking An Update Of Prescribing Information For STENDRA (Avanafil) 1/21/2014  More...
FDA Panel Once Again Rejects Wider Use Of Johnson & Johnson (JNJ) Drug 1/17/2014  More...
Merck & Co., Inc. (MRK)'s Blood Thinner, Vorapaxar, Gets "Yes" Vote From FDA Panel 1/16/2014  More...
Amarin Corporation PLC (AMRN) Slumps A Bit As FDA Delays Decision On Vascepa Trial Design 1/16/2014  More...
FDA Staff Unconvinced By Johnson & Johnson (JNJ)'s Latest Xarelto Application 1/15/2014  More...
Bristol-Myers Squibb Company (BMY) Ties Hepatitis C Success To Rival Gilead Sciences, Inc. (GILD)'s Pill 1/15/2014  More...
Chelsea Therapeutics, Inc. (CHTP) Rockets Before Market Opens After Northera Finally Wins FDA Panel Backing 1/15/2014  More...
Daiichi Sankyo, Inc. (4568.t) Submits SAVAYSA™ (Edoxaban) Tablets New Drug Application To The FDA For Once-Daily Use For Stroke Risk Reduction In Atrial Fibrillation And For The Treatment And Prevention Of Recurrence Of Venous Thromboembolism 1/14/2014  More...
INSYS Therapeutics Announces Details Of Product Development Pipeline 1/13/2014  More...
Merck & Co., Inc. (MRK) Initiates Rolling Submission Of U.S. Biologics License Application For MK-3475, An Investigational Anti-PD-1 Immunotherapy, In Patients With Advanced Melanoma 1/13/2014  More...
Ampio Pharmaceuticals, Inc. (AMPE) Injects First Patients In 2nd Phase III, Pivotal Clinical Trial For Ampion™(The STEP Study) For Its FDA Biological License Application (BLA) 1/13/2014  More...
Cynapsus Therapeutics Announces Completion Of Human Healthy Volunteer Crossover Study Results For APL-130277 1/13/2014  More...
FDA Accepts New Drug Application For Gilead Sciences, Inc. (GILD)'s Idelalisib for the Treatment of Refractory Indolent Non-Hodgkin's Lymphoma 1/13/2014  More...
Chelsea Therapeutics, Inc. (CHTP) Blues: FDA Reviewer Still Finds Problems With Fainting Drug Northera 1/13/2014  More...
NPS Pharmaceuticals, Inc. (NPSP) Announces FDA Acceptance Of Biologics License Application For Natpara® For The Treatment Of Hypoparathyroidism 1/8/2014  More...
Karyopharm Therapeutics (KPTI) Announces Submission Of New Animal Drug Application Effectiveness And Safety Sections For Novel, Oral, Small-Molecule Selective Inhibitor Of Nuclear Export (SINE) Verdinexor For Canine Lymphoma To FDA's Center For Veterinary Medicine 1/7/2014  More...
AEterna Zentaris (AEZS) NDA For Macimorelin Acetate In AGHD Accepted For Filing By The FDA 1/6/2014  More...
IGI Laboratories, Inc. Completes Its Sixth ANDA Filing For 2013 Under Joint Drug Development And Commercialization Agreement 1/2/2014  More...
FDA Turns Its Nose Up At Genzyme Corporation (GENZ)'s Lemtrada™ 12/31/2013  More...
Veloxis Pharmaceuticals A/S (VELO) Announces NDA Submission For Envarsus® In Kidney Transplant Recipients 12/30/2013  More...
Cubist Pharmaceuticals, Inc. (CBST) Announces FDA Acceptance Of Tedizolid New Drug Application With Priority Review 12/30/2013  More...
Actavis (ACT) Denies FDA' Contraceptive Patch, Seeks More Data 12/30/2013  More...
Swedish Orphan Biovitrum To Temporarily Withdraw New Drug Application For Orfadin® Oral Suspension In The US 12/27/2013  More...
ALK Announces FDA Advisory Committee To Review Ragweed Sublingual AIT Tablet 12/27/2013  More...
FDA Agrees To Review Eli Lilly and Company (LLY)/Boehringer Ingelheim Corporation's Lantus Biosimilar 12/23/2013  More...
Titan Pharmaceuticals (TTP) Receives Official Minutes From FDA Meeting On Probuphine New Drug Application 12/23/2013  More...
Biocryst Pharmaceuticals (BCRX) Files For Government-Funded Flu Treatment 12/20/2013  More...
Novo Nordisk A/S (NVO) Files For Regulatory Approval Of Liraglutide 3 Mg For The Treatment Of Obesity 12/20/2013  More...
Bristol-Myers Squibb Company (BMY) Release: FDA Accepts For Review ELIQUIS® (apixaban) Supplemental New Drug Application For The Treatment Of Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE), And For The Reduction In The Risk Of Recurrent DVT And PE 12/20/2013  More...
Auxilium Pharmaceuticals (AUXL) Submits Application To The FDA Requesting Approval Of XIAFLEX® For Concurrent Treatment Of Multiple Palpable Cords 12/20/2013  More...
Eli Lilly and Company (LLY) And Boehringer Ingelheim Corporation Announce New Drug Application Filing In The U.S. For New Insulin Glargine Product 12/20/2013  More...
Amarin Corporation PLC (AMRN) Jumps As FDA Ruling on Fish Oil Pill Gets Delayed; Stock Up +25.47% At Market Close (Dec. 20, 2013) 12/20/2013  More...
Alimera Sciences (ALIM), pSivida Corp (PSDV) Rocket On FDA Labeling Talks For Eye Drug 12/20/2013  More...
GlaxoSmithKline (GSK) And Genmab A/S (GEN.CO) Receive Priority Review From FDA For Arzerra® (Ofatumumab) As 1st Line Treatment For Chronic Lymphocytic Leukemia (CLL) 12/18/2013  More...
Regeneron Pharmaceuticals, Inc. (REGN): FDA Accepts sBLA For EYLEA 12/18/2013  More...
Ultragenyx Pharmaceuticals Investigational New Drug Application For Triheptanoin For The Treatment Of Glucose Transporter Type-1 Deficiency Syndrome Is In Effect 12/17/2013  More...
Navidea Biopharmaceuticals (NAVB) Submits Supplemental New Drug Application (Snda) For Lymphoseek® For Sentinel Lymph Node Detection In Patients With Head And Neck Cancer 12/17/2013  More...
EU Agency Due To Give Verdict On Teva Pharmaceutical Industries Limited (TEVA) MS Pill This Week 12/17/2013  More...
FDA Panel Backs Merck & Co., Inc. (MRK)'s Allergy Drug, Deems Grastek Effective 12/16/2013  More...
Johnson & Johnson (JNJ)'s Combo Diabetes Drug Held Up By FDA 12/16/2013  More...
Janssen Research & Development Release: FDA Issues Complete Response Letter For Canagliflozin/Metformin Fixed-Dose Combination Therapy For Type 2 Diabetes 12/13/2013  More...
Sprout Pharmaceuticals's Female Libido Drug Gets No Love From The FDA, Company Plans To Appeal 12/13/2013  More...
FDA Panel Backs AstraZeneca PLC (AZN), Bristol-Myers Squibb Company (BMY)'s Diabetes Drug Dapagliflozin After Initial Rebuff 12/13/2013  More...
FDA Panel Has Split Vote On Bristol-Myers Squibb Company (BMY)'s Fat Disorder Drug Metreleptin 12/13/2013  More...
FDA Advisory Committee Supports Approval Of Stallergenes, S.A. (GENP.PA)'s ORALAIR(R) For The Treatment Of Grass Pollen Allergy 12/12/2013  More...
Genzyme Corporation (GENZ)'s Gaucher Pill Application Gets Priority FDA Review 12/11/2013  More...
Sprout Pharmaceuticals Appeals FDA Decision On New Drug Application For Flibanserin To Treat Hypoactive Sexual Desire Disorder In Premenopausal Women 12/11/2013  More...
Orexigen Therapeutics, Inc. (OREX) Resubmits Contrave New Drug Application 12/11/2013  More...
FDA Panel Backs Takeda Pharmaceutical Co. Ltd. (TKPYY) Bowel Disease Drug 12/10/2013  More...
TopoTarget A/S Release: New Drug Application For Belinostat In Relapsed Or Refractory PTCL Submitted To The FDA In The USA 12/10/2013  More...
Baxter International, Inc. (BAX) Submits Application For FDA Approval Of OBI-1 For Patients With Acquired Hemophilia A 12/10/2013  More...
Spectrum Pharmaceuticals, Inc. (SPPI) Announces Submission Of New Drug Application For Belinostat, A Novel Pan-HDAC inhibitor 12/10/2013  More...
Savara Announces FDA Grant of Qualified Infectious Disease Product (QIDP) And Fast Track Designation For Its Lead Product, AeroVanc 12/10/2013  More...
ALK Announces Posting Of Briefing Documents For FDA Advisory Committee Meeting On The Grass Sublingual AIT Tablet 12/10/2013  More...
Bristol-Myers Squibb Company (BMY)'s Fat Disorder Drug May Work, But Is Risky — FDA Staff 12/10/2013  More...
FDA Staff Cautious On AstraZeneca PLC (AZN), Bristol-Myers Squibb Company (BMY) Diabetes Drug 12/10/2013  More...
Baxter International, Inc. (BAX) Files For Pediatric Indication Of RIXUBIS [Coagulation Factor IX (Recombinant)] Treatment For Hemophilia B In The United States 12/9/2013  More...
Takeda's Inflammatory Bowel Drug's Risks Questioned 12/5/2013  More...
AcelRx Pharmaceuticals (ACRX) Release: Zalviso™ New Drug Application Accepted For Filing By FDA 12/3/2013  More...
Ampio Pharmaceuticals, Inc. (AMPE) Receives FDA Confirmation That The Spring Study Is Pivotal And Will Initiate The Final Pivotal Trial For Ampion™ Biological License Application (BLA) 12/3/2013  More...
Immune Response BioPharma To File Remune BLA With FDA By March 1st 2014 Submits Fee Waiver Request 12/3/2013  More...
FDA Extends Review Of Biogen Idec, Inc. (Massachusetts) (BIIB)'s Hemophilia Drug ALPROLIX™ 12/2/2013  More...
Baxter International, Inc. (BAX) Submits Amended BLA To U.S. FDA for Hyqvia For Primary Immunodeficiency 12/2/2013  More...
Durata Therapeutics, Inc.  (DRTX) Announces FDA's Acceptance For Priority Review Of NDA For Dalvance™ (Dalbavancin Hydrochloride) 11/27/2013  More...
QRxPharma Pty Ltd. Refiles MOXDUO® New Drug Application With The FDA 11/26/2013  More...
FDA Accepts For Review Purdue Pharma L.P.'s New Drug Application For Targiniq™ ER (oxycodone HCl/naloxone HCL Controlled-Release) Tablets CII 11/26/2013  More...
Avedro, Inc. Announces FDA Priority Review Status For Corneal Cross-linking New Drug Application 11/25/2013  More...
FDA Extends Review of Mallinckrodt Pharmaceuticals (MNK)' New Drug Application For XARTEMIS™ XR (Oxycodone Hydrochloride And Acetaminophen) Extended-Release Tablets (CII) 11/25/2013  More...
Amarin Corporation PLC (AMRN) Plunges After Lead Drug Is Dealt Another Setback; Stock Down -11.51% At Market Close (November 22, 2013) 11/22/2013  More...
FDA Declines To Approve Forest Laboratories, Inc. (FRX), Gedeon Richter Ltd.'s New Antipsychotic Drug 11/22/2013  More...
Perrigo Company (PRGO) Confirms Filing For Generic Version Of Acanya 11/20/2013  More...
BioMarin Pharmaceutical Inc. (BMRN) Wins FDA Panel's Blessing For Rare Disease Drug 11/20/2013  More...
Nektar Therapeutics (CA) (NKTR) Release: New Drug Application For Naloxegol Accepted By FDA 11/19/2013  More...
BioMarin Pharmaceutical Inc. (BMRN) Release: FDA Posts Briefing Documents For Advisory Committee Meeting Reviewing Vimizim™ For The Treatment Of Morquio A Syndrome 11/18/2013  More...
BioMarin Pharmaceutical Inc. (BMRN) Announces French ATU Granted for Vimizim™ for the Treatment of Morquio A Syndrome 11/15/2013  More...
Sanofi (France) (SAN.PA) MS Drug’s Mixed Verdict From FDA Panel Puzzles Analysts 11/14/2013  More...
Vanda Pharmaceuticals, Inc. (VNDA) Stock Trading Halted; FDA Advisory Committee to Review HETLIOZ™ NDA 11/14/2013  More...
Biogen Idec, Inc. (Massachusetts) (BIIB), Swedish Orphan Biovitrum Hemophilia Drug Delayed As FDA Seeks More Info 11/13/2013  More...
NPS Pharmaceuticals, Inc. (NPSP) Announces FDA Acceptance of Supplemental New Drug Application For Gattex® (Teduglutide [rDNA Origin]) For Injection 11/13/2013  More...
Sarepta Therapeutics (Formerly known as AVI BioPharma, Inc.) (SRPT) Crumbles as FDA Wants More Testing Of Muscular Disease Drug Eteplirsen; Stock Down -64.01% At Market Close (November 12, 2013) 11/13/2013  More...
Vanda Pharmaceuticals, Inc. (VNDA)'s Experimental Drug Helps The Blind Sleep, FDA Staff Says; Stock Soars +95.93% At Market Close (November 12, 2013) 11/12/2013  More...
Shield Therapeutics Files Investigational New Drug Application For ST10 For The Treatment Of Iron Deficiency In Chronic Kidney Disease 11/12/2013  More...
Amarin Corporation PLC (AMRN) Appeals FDA Rescission of Special Protocol Agreement 11/8/2013  More...
AEterna Zentaris (AEZS) Submits New Drug Application to FDA for Macimorelin Acetate (AEZS-130) for Evaluation of AGHD 11/5/2013  More...
UCB, Inc. (UCBJF.PK) Files VIMPAT® (Lacosamide) in the U.S. as Monotherapy Treatment in Adult Epilepsy Patients With Partial-Onset Seizures 11/4/2013  More...
CureMark Begins NDA Submission for CM-AT Autism Treatment 11/4/2013  More...
IGI Laboratories, Inc. Announces Thirteenth ANDA Submission 11/1/2013  More...
Baxter International, Inc. (BAX) Submits Application for European Approval of RIXUBIS, Recombinant Factor IX (nonacog gamma) for Hemophilia B 10/31/2013  More...
MannKind Corporation (MNKD) Announces FDA Acknowledgement of Resubmission of New Drug Application for AFREZZA 10/30/2013  More...
FDA Continues to Throw Cold Water on Amarin Corporation PLC (AMRN)'s Hopes for Vascepa 10/30/2013  More...
Swedish Orphan Biovitrum Submits Application for Orfadin® Oral Suspension to FDA 10/29/2013  More...
Innovus Pharma Files Its Product License Application for Commercialization of EjectDelay™ for Premature Ejaculation in Canada 10/29/2013  More...
FDA Panel Backs Gilead Sciences, Inc. (GILD) Hepatitis C Drug Sofosbuvir 10/29/2013  More...
FDA Advisory Panel Backs Approval of Johnson & Johnson (JNJ)'s Hepatitis C Drug 10/28/2013  More...
NPS Pharmaceuticals, Inc. (NPSP) Submits Biologic License Application to the FDA for Natpara® in Hypoparathyroidism 10/25/2013  More...
FDA Questions Credibility of Repros Therapeutics Inc. (RPRX)'s Androxal® Data 10/24/2013  More...
FDA Grants Eli Lilly and Company (LLY)'s Ramucirumab Priority Review as a Potential Single-Agent Treatment for Advanced Gastric Cancer 10/23/2013  More...
Cubist Pharmaceuticals, Inc. (CBST) Announces Submission of New Drug Application for Investigational Antibiotic Tedizolid for Treatment of Serious Skin Infections 10/22/2013  More...
FDA Panel Backs Paladin Labs Inc. (CC:PLB)' Parasitic Disease Drug 10/21/2013  More...
Osiris Therapeutics, Inc. (OSIR) and FDA Reach Agreement on Regulatory Pathway for Biosurgery Products 10/21/2013  More...
Alimera Sciences (ALIM), pSivida Corp (PSDV) Stocks Plunge After Drug Fails to Win FDA Approval Again 10/18/2013  More...
Amarin Corporation PLC (AMRN) Plummets After Fish Oil Pill Fails to Win Backing; Stock Down -61.12% at Market Close (October 17, 2013) 10/18/2013  More...
Amarin Corporation PLC (AMRN) Stock Trading Halted Today; FDA Advisory Committee to Review sNDA for Vascepa® ANCHOR Indication 10/16/2013  More...
Why the FDA Probably Won't Approve an Expanded Indication for Amarin Corporation PLC (AMRN)'s Vascepa 10/16/2013  More...
MannKind Corporation (MNKD) Resubmits New Drug Application to FDA for AFREZZA for the Treatment of Adults With Diabetes 10/14/2013  More...
FDA Files Genentech (RHHBY)'s Supplemental Biologics License Application of Xolair® 10/11/2013  More...
Chelsea Therapeutics, Inc. (CHTP) Announces FDA Advisory Committee to Review NORTHERA™ (droxidopa) 10/10/2013  More...
BioDelivery Sciences International (BDSI) Announces FDA Acceptance of BUNAVAIL NDA for Filing 10/9/2013  More...
Amarin Corporation PLC (AMRN) to Host Conference Call on October 16, 2013 to Discuss Results of FDA Advisory Committee Meeting on ANCHOR Supplemental New Drug Application (sNDA) for Vascepa® 10/9/2013  More...
QRxPharma Pty Ltd. Reports Positive Meeting With the FDA on MOXDUO® 10/9/2013  More...
Bioniche Life Sciences Inc. (BNC) Provides an Update on Plans for a New Drug Submission Filing in Canada 10/8/2013  More...
Keryx Biopharmaceuticals (KERX) Announces FDA Acceptance for Filing of Zerenex™ New Drug Application 10/8/2013  More...
ALK-Abello A/S Release: FDA Postpones Advisory Committee Meeting for Grass AIT Tablet Due to US Government Shutdown 10/8/2013  More...
Lannett Company, Inc. (LCI) Provides Product Development Update on Thalidomide Capsules 10/8/2013  More...
Par Pharmaceutical Companies, Inc. (PRX) Begins Shipment of Generic Kapvay® 10/7/2013  More...
Ligand Pharmaceuticals Inc. (LGND) Announces FDA Acceptance of Investigational New Drug Application for Glucagon Receptor Antagonist Program 10/7/2013  More...
Amarin Corporation PLC (AMRN) Informed by FDA That October 16th Advisory Committee Meeting Will Take Place as Scheduled 10/3/2013  More...
Zogenix, Inc. Provides Update on Zohydro™ ER NDA 10/2/2013  More...
AcelRx Pharmaceuticals (ACRX) Submits New Drug Application to the FDA for Zalviso™ 9/30/2013  More...
Vertex Pharmaceuticals (MA) (VRTX) Submits Supplemental New Drug Application (sNDA) to FDA for KALYDECO™ (ivacaftor) Monotherapy for People With Non-G551D Gating Mutations 9/30/2013  More...
Durata Therapeutics, Inc.  (DRTX) Announces NDA Submission for Dalbavancin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections (ABSSSI) 9/27/2013  More...
Titan Pharmaceuticals (TTP) Announces Confirmation of Meeting With FDA Regarding Probuphine 9/27/2013  More...
Merck & Co., Inc. (MRK) Dealt Another Setback as FDA Rejects Anesthesia Drug Again 9/24/2013  More...
Swedish Orphan Biovitrum Receives Positive CHMP Opinion for Kineret® for Treatment of Rare Disease CAPS 9/23/2013  More...
Sunovion Pharmaceuticals Canada Inc. Announces Health Canada Acceptance for Review of the New Drug Submission of eslicarbazepine acetate as a Once-Daily Adjunctive Therapy for Partial-onset Seizures in Adults with Epilepsy 9/19/2013  More...
IGI Laboratories, Inc. Announces Twelfth ANDA Submission 9/19/2013  More...
AstraZeneca PLC (AZN) Looks for New Heart Drug Approval by Next May 9/18/2013  More...





 

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