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Clinical - BLA/NDA/ANDA
TaiGen Biotechnology Announces Submission of New Drug Application for Nemonoxacin in Taiwan and Mainland China 5/16/2013 10:06:47 AM    More...
Johnson & Johnson (JNJ) Unit Gets Priority Revenue for Simeprevir NDA 5/14/2013 7:37:31 AM    More...
Seattle Genetics, Inc. (SGEN) Announces ADCETRIS® (Brentuximab Vedotin) Supplemental BLA Accepted for Filing by the FDA 5/14/2013 10:53:54 AM    More...
TWi Pharmaceuticals, Inc. Announces Tentative ANDA Approval for Guanfacine Hydrochloride Extended-Release Tablets 5/14/2013 9:35:08 AM    More...
FDA Accepts Biogen Idec, Inc. (Massachusetts) (BIIB)’s Biologics License Application for First Long-Lasting Factor VIII Therapy for Hemophilia A 5/13/2013 11:06:30 AM    More...
FDA Rejects Endo Health Solutions Inc. (Formerly Known as Endo Pharmaceuticals Holdings Inc.) (ENDP) Petition to Protect Its Painkiller Franchise 5/13/2013 8:23:48 AM    More...
Actavis (ACT)' NDA for Progestin-Only Patch Accepted for Filing by FDA 5/13/2013 10:03:24 AM    More...
Janssen Research & Development Release: FDA Grants Priority Review to Simeprevir (TMC435) for Combination Treatment of Genotype 1 Chronic Hepatitis C 5/13/2013 10:01:31 AM    More...
Pfizer Inc. (PFE) Yet to Decide on Pain Therapeutics Painkiller 5/10/2013 7:41:47 AM    More...
Merck & Co., Inc. (MRK) Announces FDA Acceptance of Biologics License Application for Investigational Ragweed Pollen Sublingual Allergy Immunotherapy Tablet 5/8/2013 10:51:36 AM    More...
Gilead Sciences, Inc. (GILD) Fails FDA Approval for Two HIV Drugs in 4-in-1 Pill 4/29/2013 8:38:51 AM    More...
FDA Committee Turns Down AVEO Oncology (Formerly known as AVEO Pharmaceuticals, Inc.) (AVEO)/Astellas Pharma Inc. (YPH.BE)'s Cancer Drug 5/3/2013 7:41:57 AM    More...
FDA Delays Approval of Titan Pharmaceuticals (TTP)'s Suboxone Implant 5/1/2013 8:33:36 AM    More...
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 11:52:14 AM    More...
CureMark Announces Positive Pre-NDA Meeting With FDA for New Drug Application for CM-AT for Autism 4/23/2013 10:34:55 AM    More...
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