FDA CRL Delays Bitopertin Approval for Rare EPP Disease
WATERTOWN, Mass., Feb. 13, 2026 — Disc Medicine announced that the U.S. Food and Drug Administration has issued a...
Phase 3 trial
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FAPI-74 Phase 3 Trial Doses First Pancreatic Patient
DULLES, Va., Feb. 11, 2026 — SOFIE Biosciences announced that the first patient has been dosed in its Phase...
Ameluz® PDT Phase 3 Trial Meets Primary Endpoint
WOBURN, Mass., Feb. 9, 2026 — Biofrontera Inc. announced positive top-line results from its multicenter Phase 3 clinical trial...
FDA Approves DARZALEX FASPRO Quadruplet for NDMM Care
HORSHAM, PENNSYLVANIA | January 27, 2026 — Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA)...
FDA Clears Scancell IND for Phase 3 iSCIB1+ Melanoma Trial
Cambridge, United Kingdom, January 26, 2026 — Scancell Holdings plc announced on January 26, 2026, that the U.S. Food...
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Legacy Advances Cinainu into Phase 3 Alopecia Areata Trial
LAUSANNE, Switzerland | January 6, 2026 — Legacy Healthcare announced that it will advance its topical botanical drug candidate,...
Lilly’s Oral GLP-1 Orforglipron Sustains Weight Loss in Phase 3 Trial
Indianapolis, December 18, 2025 — Eli Lilly and Company announced positive topline results from its first-of-its-kind Phase 3 ATTAIN-MAINTAIN...
KEYTRUDA Plus Padcev Extends Survival in MIBC Trial
RAHWAY, N.J., Dec. 17, 2025 — Merck (NYSE: MRK) announced positive topline results from the Phase 3 KEYNOTE-B15 (EV-304)...
Positive Zoliflodacin Phase 3 Data Published in The Lancet
LONDON, December 12, 2025 — Innoviva Specialty Therapeutics announced the publication of positive Phase 3 clinical results for zoliflodacin...
Lilly’s Retatrutide Achieves Major Gains in Weight and Pain Relief
INDIANAPOLIS, December 11, 2025 — Eli Lilly and Company announced positive topline results from the Phase 3 TRIUMPH-4 trial,...
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