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https://www.pdufa.bio/fda-decision/GSK-2026-03-19 Linerixibat Approved Mar 17, 2026 | GSK FDA Decision | pdufa.bio Oct 4, 2026 - GSK: Linerixibat was approved on March 17, 2026 (announced March 19, 2026). Decision source document and the 120-trading-day run-up into the date. linerixibat approved mar gsk fda https://www.pdufa.bio/drug/cm4620 CM4620: FDA Decision Dates & Catalyst History | pdufa.bio Oct 13, 2026 - CM4620: FDA catalyst dates and outcomes. For CalciMedica, Inc. Every date and decision links its primary source. Facts only. fda decision dates catalyst history https://www.pdufa.bio/coverage Data Coverage & Integrity | pdufa.bio Aug 15, 2026 - How complete and fresh pdufa.bio is: catalysts tracked, % with primary-source links, PDUFA recall, date-precision, and explicit limitations. data coverage integrity pdufa bio https://pipelineroad.com/news/20260317-polypid-receives-4-3-million-fda-pdufa-fee-waiver-for-d-plex PolyPid Receives $4.3 Million FDA PDUFA Fee Waiver for D-PLEX100 ND... Mar 17, 2026 - PolyPid Ltd. announced on March 17, 2026, that the FDA granted a $4.3 million PDUFA fee waiver for D-PLEX100's New Drug Application, aiding… receives million fda pdufa fee https://www.pdufa.bio/fda-decision/XNCR-2025-06-18 MONJUVI Approved Jun 18, 2025 | XNCR FDA Decision | pdufa.bio Oct 14, 2026 - XNCR: MONJUVI was approved on June 18, 2025. Decision source document and the 120-trading-day run-up into the date. monjuvi approved jun fda decision https://www.clinuvel.com/2019/10/fda-clarifies-scenesse-pdufa-date/ FDA Clarifies SCENESSE® PDUFA Date - CLINUVEL Oct 2, 2019 - CLINUVEL PHARMACEUTICALS LTD today announced that the US Food and Drug Administration (FDA) has notified the company that the Prescription Drug User Fee Act... pdufa date fda clarifies https://catalyst-ventures.eu/catalysts/event/SECREG-VTRS-PDUFA-2026-12-27 VTRS PDUFA decision: Sunday, December 27, 2026 Viatris Inc. PDUFA decision on Sunday, December 27, 2026. Source: SEC 8-K filing. Free biotech catalyst calendar with US and EU coverage. vtrs pdufa decision sunday december https://www.biotech-now.org/press-release/bio-supports-pdufa-viii-commitment-letter-and-urges-timely-reauthorization BIO Supports PDUFA VIII Commitment Letter and Urges Timely Reauthorization | BIO commitment letter bio supports pdufa viii https://dansfera.com/drug/relacorilant-cort-hypercortisolism-crl relacorilant (CORT) — PDUFA December 30, 2025 | Dan Sfera PDUFA catalyst: relacorilant by Corcept Therapeutics. FDA target action date — December 30, 2025. Hypertension secondary to endogenous hypercortisolism... relacorilant cort pdufa december dan https://animedix.com/news/pdufa-calendar/29518b83-d969-44e3-b608-cdb33af94d59 Gedatolisib PDUFA Date — Celcuity FDA PDUFA decision date for Gedatolisib is July 17, 2026. Developed by Celcuity. Indication: HR+/HER2- PIK3CA wildtype advanced breast cancer. Current status:... pdufa date gedatolisib https://www.pdufa.bio/ticker/GKOS GLAUKOS Corp (GKOS) FDA Catalysts | pdufa.bio Oct 13, 2026 - GLAUKOS Corp (GKOS) FDA catalyst hub. 2 past FDA decisions. Source document and measured run-up on every one. corp gkos fda catalysts pdufa https://www.pdufa.bio/drug/tryptyr TRYPTYR (acoltremon ophthalmic solution): FDA Decision Dates & Catalyst History | pdufa.bio Oct 13, 2026 - TRYPTYR (acoltremon ophthalmic solution): FDA approved on May 28, 2025. Catalyst history we track, every date sourced. Facts only. acoltremon ophthalmic tryptyr solution fda decision https://www.biocentury.com/article/20663/reconciled-pdufa-bill-omits-rems-provision BioCentury - Reconciled PDUFA bill omits REMS provision Congress released late Monday a reconciled PDUFA reauthorization bill that excludes a pay-for provision in the Senate version of the bill that would have r... reconciled pdufa bill omits rems https://www.pdufa.bio/drug/trodelvy Trodelvy (sacituzumab govitecan-hziy): FDA Decision Dates & Catalyst History | pdufa.bio Oct 13, 2026 - Trodelvy (sacituzumab govitecan-hziy): FDA approved on June 24, 2026. Catalyst history we track, every date sourced. Facts only. sacituzumab govitecan trodelvy fda decision dates https://www.pdufa.bio/drug/relutrigine Relutrigine (PRAX-562): FDA Decision Dates & Catalyst History | pdufa.bio Oct 13, 2026 - Relutrigine (PRAX-562): FDA PDUFA date December 27, 2026. For Praxis Precision Medicines Inc. Catalyst history we track, every date sourced. Facts only. relutrigine prax fda decision dates