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FDA Acceptance

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Averitas Pharma, Inc.
FDA Acceptance

Averitas Pharma Announces FDA Acceptance for Neuropathic Pain Treatment

Averitas Pharma, Inc.

PR-M12-19-NI-032Dec 20, 2019
Novartis
FDA Acceptance

FDA Accepts File and Accelerates Review of Novartis Sickle Cell Disease Medicine Crizanlizumab (SEG101)

Novartis

PR-M07-19-NI-048Jul 18, 2019
Novartis
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
Exeltis
FDA Acceptance

FDA Accepts Filing of New Estrogen-free Oral Contraceptive Developed by Exeltis

Exeltis

PR-M12-18-NI-030Dec 10, 2018
Competitive Generic Therapy: A New Patient-Centric FDA Pathway
Regulatory

Competitive Generic Therapy: A New Patient-Centric FDA Pathway

David Alvaro, Ph.D.

Pharma's Almanac

PAP-Q3-18-NI-008Oct 02, 2018
Glenmark Pharmaceuticals
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
Bausch + Lomb
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
Sage Therapeutics
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
Exelixis
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
Bayer
Drug Application

FDA Accepts Larotrectinib New Drug Application and Grants Priority Review

Bayer

PR-M05-18-NI-115May 31, 2018
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