Gossamer Bio Reacquires Global Rights to Seralutinib
San Diego, California, July 27, 2026 Gossamer Bio, Inc. announced a series of significant regulatory, strategic, and financial milestones...
NDA Submission
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Immunome Files FDA NDA for Varegacestat in Tumors
BOTHELL, WASHINGTON, April 29, 2026 Immunome has announced the submission of a New Drug Application (NDA) to the U.S....
Ocular Therapeutix AXPAXLI Shows Strong Phase 3 AMD
BEDFORD, Mass., April 13, 2026 Ocular Therapeutix, Inc. has reported positive Week 52 data from its Phase 3 SOL-1...
Nuvalent Submits NDA for Neladalkib in ALK Lung Cancer
CAMBRIDGE, Mass., April 7, 2026 Nuvalent, Inc. has announced the submission of a New Drug Application (NDA) to the...
Cogent NDA for Bezuclastinib Advances Under FDA RTOR
WALTHAM, Mass. & BOULDER, Colo., January 20, 2026 — Cogent Biosciences announced that the U.S. Food and Drug Administration...
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Axsome Advances AXS-12 Toward NDA for Narcolepsy
NEW YORK | December 31, 2025 — Axsome Therapeutics announced it has received formal FDA pre–New Drug Application (Pre-NDA)...
Cogent Submits NDA for Bezuclastinib in Mastocytosis
Waltham, Massachusetts & Boulder, Colorado | December 30, 2025 — Cogent Biosciences, Inc. has announced the submission of a...
Eisai Files NDA in Japan for Subcutaneous Leqembi to Expand Alzheimer’s Access
TOKYO & STOCKHOLM — November 28, 2025. Eisai, in partnership with BioArctic, has submitted a New Drug Application (NDA)...
Zipalertinib Advances With FDA Rolling NDA Submission
PRINCETON, NJ — November 20 , 2025 — Taiho Oncology, Taiho Pharmaceutical, and Cullinan Therapeutics announced the initiation of...
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