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FDA Acceptance
11 Articles Available
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FDA Acceptance
Averitas Pharma Announces FDA Acceptance for Neuropathic Pain Treatment
PR-M12-19-NI-032
FDA Acceptance
FDA Accepts File and Accelerates Review of Novartis Sickle Cell Disease Medicine Crizanlizumab (SEG101)
PR-M07-19-NI-048
FDA Acceptance
Novartis Announces FDA Filing Acceptance and Priority Review of Brolucizumab (RTH258) for Patients with Wet AMD
PR-M04-19-NI-053
FDA Acceptance
FDA Accepts Filing of New Estrogen-free Oral Contraceptive Developed by Exeltis
PR-M12-18-NI-030
Regulatory
Competitive Generic Therapy: A New Patient-Centric FDA Pathway
PAP-Q3-18-NI-008
FDA Acceptance
Glenmark Pharmaceuticals Announces FDA Acceptance of the Company's First New Drug Application for Ryaltris™ for Patients with Seasonal Allergic Rhinitis
PR-M08-18-NI-060
FDA Filing Acceptance
Bausch + Lomb Announces U.S. FDA Filing Acceptance For Loteprednol Etabonate Ophthalmic Gel, 0.38%
PR-M07-18-NI-029
FDA Acceptance
Sage Therapeutics Announces FDA Acceptance of NDA Filing and Grant of Priority Review for Brexanolone IV in the Treatment of Postpartum Depression
PR-M06-18-NI-007
NDA
Exelixis Announces U.S. FDA Accepts Supplemental New Drug Application for CABOMETYX® (cabozantinib) in Previously Treated Advanced Hepatocellular Carcinoma
PR-M06-18-NI-003
Drug Application
FDA Accepts Larotrectinib New Drug Application and Grants Priority Review
PR-M05-18-NI-115
Cell and Gene Therapy
Bioverativ and Sangamo Announce FDA Acceptance of IND Application for Gene-Edited Cell Therapy BIVV003 to Treat Sickle Cell Disease
PR-M05-18-NI-074
