HUTCHMED and AstraZeneca Submit US NDA for ORPATHYS Plus TAGRISSO
HONG KONG, SHANGHAI and FLORHAM PARK, N.J. — September 29, 2026 HUTCHMED (China) Limited announced that AstraZeneca has submitted...
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LEO Pharma Gains FDA Priority Review for Dersimelagon
BALLERUP, Denmark — September 18, 2026 LEO Pharma announced that the U.S. Food and Drug Administration (FDA) has accepted...
Orbis Medicines and Novo Nordisk Form $1.4B Discovery Deal
COPENHAGEN, Denmark — September 17, 2026 Orbis Medicines announced a strategic collaboration and license agreement with Novo Nordisk to...
Aquestive Resubmits Anaphylm NDA to FDA
WARREN, N.J. — September 17, 2026 Aquestive Therapeutics announced the resubmission of its New Drug Application (NDA) to the...
Ocular Therapeutix Advances AXPAXLI Toward Wet AMD NDA
BEDFORD, Mass. — September 15, 2026 Ocular Therapeutix, Inc. announced the successful completion of its Pre-New Drug Application (Pre-NDA)...
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Adneuris Advances Cebranopadol Toward Acute Pain NDA
MONMOUTH JUNCTION, N.J. — September 10, 2026 Adneuris Therapeutics presented new clinical and abuse-potential data for cebranopadol at PAINWeek...
Compass Pathways Advances COMP360 Toward Potential TRD Launch
LONDON and NEW YORK — September 9, 2026 Compass Pathways plc announced positive topline 52-week open-label results from Part...
BridgeBio Advances Oral Infigratinib Toward Achondroplasia Launch
PALO ALTO, Calif. — September 9, 2026 BridgeBio Pharma, Inc. presented new exploratory analyses from the Phase 3 PROPEL...
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)...
Telix Completes BiPASS Enrollment and Aligns With FDA
MELBOURNE, Australia and INDIANAPOLIS, September 2, 2026 Telix Pharmaceuticals Limited has completed enrollment of 350 patients in its Phase...
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