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Clinical - BLA/NDA/ANDA
Regeneron (REGN)-Sanofi (SAN.PA) Gain Edge On Amgen (AMGN) as Cholesterol Drug Snags FDA Priority Review 1/26/2015 6:26:26 AM
Antares Pharma, Inc. (ATRS) Provides Regulatory Update On Sumatriptan Injection USP 1/26/2015 10:51:12 AM
Regeneron (REGN) And Sanofi (SAN.PA) Announce Praluentâ„¢ (Alirocumab) Biologics License Application Has Been Accepted For Priority Review By FDA 1/26/2015 6:24:59 AM
FDA Panel Backs Astellas Pharma Inc. (ALPMY)'s CRESEMBA for Invasive Fungal Infections 1/22/2015 7:36:47 AM
KYTHERA Biopharmaceuticals, Inc. (KYTH) Announces Date Of FDA Advisory Committee Review Of ATX-101 For The Treatment Of Submental Fullness 1/23/2015 7:36:00 AM
Astellas Pharma Inc. (ALPMY) Announces FDA Anti-Infective Drugs Advisory Committee Recommends Approval Of CRESEMBA® (Isavuconazonium) For Treatment Of Invasive Aspergillosis And Mucormycosis 1/23/2015 7:03:11 AM
UCB, Inc. (UCBJF.PK) Announces US And EU Regulatory Filings For The Investigational Antiepileptic Drug brivaracetam 1/21/2015 10:05:14 AM
Premier Biomedical Files Initial FDA Submission For Fibromyalgia Treatment 1/20/2015 9:03:00 AM
FDA Grants Priority Review For Three-Month Paliperidone Palmitate For The Treatment Of Schizophrenia 1/19/2015 11:07:51 AM
Pernix Therapeutics, Inc. (PTX) Announces FDA Acceptance With Priority Review Of Its TREXIMET® sNDA For Use In Adolescent Patients 1/16/2015 10:15:06 AM
Pfizer (PFE)'s New Type of Cancer Drug May Get Early Approval: Analysts 1/9/2015 6:09:32 AM
Evofem, Inc. Announces Pre-NDA Meeting With FDA For Amphora® 1/13/2015 6:48:30 AM
Neos Therapeutics Announces Submission Of A New Drug Application For Its Methylphenidate Extended Release Oral Disintegrating Tablet (XR-ODT) For The Treatment Of ADHD 1/12/2015 11:55:55 AM
BioRestorative Therapies, Inc. Reports Successful Meeting With FDA 1/12/2015 11:15:55 AM
Hospira, Inc. Submits New Biologics License Application To U.S. FDA For Proposed Epoetin Alfa Biosimilar 1/12/2015 8:45:01 AM
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