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Clinical - BLA/NDA/ANDA
Sarepta Therapeutics (SRPT) Erupts On Optimism Over Muscular Dystrophy Drug; Stock Up +36.08% At 8:49 ET On Monday 4/21/2014 7:06:54 AM    More...
Amgen (AMGN)'s Heart Failure Drug Ivabradine Wins Fast Track Status From The FDA 4/18/2014 8:01:01 AM    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 9:36:33 AM    More...
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 8:22:09 AM    More...
Bay Area's IMPAX Laboratories, Inc. (IPXL) Tries Again With Once-Rebuffed Parkinson's Drug Rytary 4/11/2014 7:20:36 AM    More...
Pharmacyclics, Inc. (PCYC) Files Supplemental New Drug Application For IMBRUVICA With Phase III CLL Study Data 4/8/2014 9:25:10 AM    More...
Janssen Research & Development Release: Supplemental New Drug Application For IMBRUVICA™ (ibrutinib) Submitted To The U.S. FDA 4/8/2014 9:13:05 AM    More...
Sanofi (France) (SAN.PA) Will Try Again, To Resubmit Lemtrada Application For FDA Review 4/7/2014 6:19:11 AM    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 9:28:15 AM    More...
Gilead Sciences, Inc. (GILD)'s Ledipasvir/Sofosbuvir Fixed-Dose Combo Hep C Tablet Wins FDA Priority Review 4/7/2014 6:37:42 AM    More...
Bristol-Myers Squibb Company (BMY) Submits NDAs For Daclatasvir And Asunaprevir To The FDA For Hepatitis C Drugs 4/7/2014 6:50:56 AM    More...
MannKind Corporation (MNKD) Rockets As FDA Panel Backs Inhaled Diabetes Drug Afrezza; Stock Up 73.88% At Market Close (April 2, 2014) 4/2/2014 7:58:18 AM    More...
Helix Biopharma (CC:HBP) Submits L-DOS47 Investigational New Drug Application With FDA 4/4/2014 10:09:19 AM    More...
FDA Accepts The Filing Of The Medicines Company (MDCO)'s US Biologic License Application For Fibrocaps Hemostatic Agent 4/4/2014 9:59:19 AM    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 7:42:43 AM    More...
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