Showing posts with label Submission. Show all posts
Showing posts with label Submission. Show all posts
Monday, September 7, 2026

Cogent Biosciences Announces Submission of New Drug Application for Bezuclastinib in Gastrointestinal Stromal Tumors (GIST)

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Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases,...
Thursday, September 3, 2026

Nuvalent Announces Submission of New Drug Application to FDA for Neladalkib in TKI Pre-treated Advanced ALK-Positive NSCLC

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Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically pr...
Monday, August 24, 2026

Immunome Announces Submission of New Drug Application to U.S. FDA for Varegacestat for the Treatment of Adults with Desmoid Tumors

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I Immunome, Inc. (Nasdaq: IMNM), a biotechnology company committed to developing first-in-class and best-in-class targeted cancer therapies,...
Wednesday, August 5, 2026

Nuvalent Announces Submission of New Drug Application to FDA for Neladalkib in TKI Pre-treated Advanced ALK-Positive NSCLC

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Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically pr...
Saturday, August 1, 2026

Cogent Biosciences Announces Submission of New Drug Application for Bezuclastinib in Gastrointestinal Stromal Tumors (GIST)

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Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases,...
Wednesday, March 27, 2019

Bayer Completes Rolling Submission of NDA for Investigational Drug Darolutamide for the Treatment of Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC)

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    Bayer  announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administra...