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FDA Acceptance
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FDA Acceptance
Averitas Pharma Announces FDA Acceptance for Neuropathic Pain Treatment
Averitas Pharma, Inc.
PR-M12-19-NI-032
Dec 20, 2019
FDA Acceptance
FDA Accepts File and Accelerates Review of Novartis Sickle Cell Disease Medicine Crizanlizumab (SEG101)
Novartis
PR-M07-19-NI-048
Jul 18, 2019
FDA Acceptance
Novartis Announces FDA Filing Acceptance and Priority Review of Brolucizumab (RTH258) for Patients with Wet AMD
Novartis
PR-M04-19-NI-053
Apr 17, 2019
FDA Acceptance
FDA Accepts Filing of New Estrogen-free Oral Contraceptive Developed by Exeltis
Exeltis
PR-M12-18-NI-030
Dec 10, 2018
Regulatory
Competitive Generic Therapy: A New Patient-Centric FDA Pathway
David Alvaro, Ph.D.
Pharma's Almanac
PAP-Q3-18-NI-008
Oct 02, 2018
FDA Acceptance
Glenmark Pharmaceuticals Announces FDA Acceptance of the Company's First New Drug Application for Ryaltris™ for Patients with Seasonal Allergic Rhinitis
Glenmark Pharmaceuticals
PR-M08-18-NI-060
Aug 15, 2018
FDA Filing Acceptance
Bausch + Lomb Announces U.S. FDA Filing Acceptance For Loteprednol Etabonate Ophthalmic Gel, 0.38%
Bausch + Lomb
PR-M07-18-NI-029
Jul 10, 2018
FDA Acceptance
Sage Therapeutics Announces FDA Acceptance of NDA Filing and Grant of Priority Review for Brexanolone IV in the Treatment of Postpartum Depression
Sage Therapeutics
PR-M06-18-NI-007
Jun 04, 2018
NDA
Exelixis Announces U.S. FDA Accepts Supplemental New Drug Application for CABOMETYX® (cabozantinib) in Previously Treated Advanced Hepatocellular Carcinoma
Exelixis
PR-M06-18-NI-003
Jun 01, 2018
Drug Application
FDA Accepts Larotrectinib New Drug Application and Grants Priority Review
Bayer
PR-M05-18-NI-115
May 31, 2018
