Belite Bio Files Japan NDA for Tinlarebant in Stargardt Disease
San Diego, California, U.S., September 8, 2026 Belite Bio has announced the submission of a New Drug Application (NDA)...
New Drug Application
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Lilly’s Mounjaro Gains FDA Approval for Heart Risk Reduction
INDIANAPOLIS, U.S., Aug 28, 2026 Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has...
Nicox Sets April 2027 FDA Decision Date for NCX 470
SOPHIA ANTIPOLIS, FRANCE, Aug 27, 2026 Nicox SA announced that the U.S. Food and Drug Administration (FDA) has accepted...
FastWave Medical Gains FDA IDE Approval for Artero IVL
Minneapolis, Minnesota, August,11, 2026 FastWave Medical has received U.S. Food and Drug Administration (FDA) approval of its Investigational Device...
EIT Pharma Gains FDA Acceptance for Lonafarnib NDA
Kirkland, Washington, August,11, 2026 EIT Pharma, Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted...
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Keenova Publishes New XIAFLEX Data in Peyronie’s Disease
Dublin, Ireland, August 3, 2026 Keenova Therapeutics plc announced the publication of a new manuscript evaluating XIAFLEX® (collagenase clostridium...
Acurx Gains FDA Guidance for Ibezapolstat Phase 3 Program
Staten Island, New York, August 3, 2026 Acurx Pharmaceuticals, Inc. announced further regulatory guidance from the U.S. Food and...
Trace Biosciences and Axogen Advance Nerve Trace Technology
PORTLAND, Ore., July 29, 2026 Trace Biosciences, Inc. has secured a strategic investment from Axogen, Inc. to accelerate clinical...
Abivax Aligns with FDA on Obefazimod NDA Submission
PARIS, France, July 30, 2026 Abivax SA announced the successful completion of a positive pre-New Drug Application (pre-NDA) interaction...
Revolution Medicines FDA Accepts Daraxonrasib NDA for Pancreatic Cancer
Revolution Medicines, Redwood City, Calif., July 22, 2026 Revolution Medicines announced that the U.S. Food and Drug Administration (FDA)...
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