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Kala Pharmaceuticals Receives FDA Complete Response Letter for KPI-121 0.25% NDA and Plans to Respond with Data From STRIDE 3 Trial drugs
August 15, 2019
Kala Pharmaceuticals, Inc. announced that it received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Company’s new drug application (NDA) for...
Takeda submits NDA for SC formation of ulcerative colitis treatment pharmaceutical-technology
August 09, 2019
Takeda Pharmaceutical has submitted a new drug application (NDA) in Japan for a subcutaneous (SC) formulation of vedolizumab to treat adults with moderately to severely active ulcerative colitis (UC).
Blueprint Medicines Announces FDA Acceptance of NDA for Avapritinib americanpharmaceuticalreview
August 09, 2019
Blueprint Medicines announced the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for avapritinib for the treatment of adult patients with ...
FDA Accepts Correvio's Resubmitted NDA for Brinavess americanpharmaceuticalreview
July 29, 2019
Correvio Pharma announced the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for Brinavess™ (vernakalant hydrochloride, IV), an antiarrhythmic drug for ...
Epizyme Announces NDA Acceptance, Priority Review for Tazemetostat americanpharmaceuticalreview
July 26, 2019
Epizyme announced the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s New Drug Application (NDA) for accelerated approval of tazemetostat, its lead investigational agent.
Vertex Submits NDA for Triple Combination of VX-445, Tezacaftor, Ivacaftor in Cystic Fibrosis americanpharmaceuticalreview
July 23, 2019
Vertex Pharmaceuticals announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the VX-445 (elexacaftor), tezacaftor and ivacaftor triple combination regimen.
FDA Accepts RedHill Biopharma’s NDA for Talicia contractpharma
July 17, 2019
Commercial launch of H. pylori treatment is planned shortly following potential FDA approval.
Neurocrine Biosciences Announces NDA Acceptance of Parkinson's Treatment americanpharmaceuticalreview
July 12, 2019
Neurocrine Biosciences announced the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for opicapone, a novel, once-daily, oral, selective catechol-O-methyltransferase (COMT) inhibitor as ...
Acacia Pharma Plans to Resubmit the Barhemsys NDA in Q3 2019 drugs
July 11, 2019
Acacia Pharma Plans to Resubmit the Barhemsys NDA in Q3 2019.
NMPA accepts NDA for biosimilar product candidate of Rituximab biospectrumasia
June 28, 2019
IBI301 is a recombinant human-mouse chimeric anti-cell surface protein (anti-CD20) monoclonal antibody for injection co-developed by Lilly and Innovent for the treatment of non-Hodgkin's lymphoma (NHL) and other diseases.

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