FDA Acceptance
Averitas Pharma Announces FDA Acceptance for Neuropathic Pain Treatment
Averitas Pharma, Inc.
PR-M12-19-NI-032Dec 20, 2019
FDA Acceptance
FDA Accepts File and Accelerates Review of Novartis Sickle Cell Disease Medicine Crizanlizumab (SEG101)
Novartis
PR-M07-19-NI-048Jul 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-053Apr 17, 2019
FDA Acceptance
FDA Accepts Filing of New Estrogen-free Oral Contraceptive Developed by Exeltis
Exeltis
PR-M12-18-NI-030Dec 10, 2018
Regulatory
Competitive Generic Therapy: A New Patient-Centric FDA Pathway
David Alvaro, Ph.D.
Pharma's Almanac
PAP-Q3-18-NI-008Oct 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-060Aug 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-029Jul 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-007Jun 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-003Jun 01, 2018
Drug Application
FDA Accepts Larotrectinib New Drug Application and Grants Priority Review
Bayer
PR-M05-18-NI-115May 31, 2018