Meddash.ai
Source-verified Clinical Evidence Briefs, Competitive Trial Landscapes, and Monthly Clinical Intelligence for biotech, medical affairs, and life sciences teams. We also deliver systematic reviews, MSL slide decks, scientific manuscript development, and biotech catalyst interpretation.
Our data models run intelligence scoping in real time, with dynamic scoring and proprietary algorithms to deliver actionable intelligence for today and predictive intelligence for tomorrow.
Only independently approved, primary-source-linked events appear here.
Capricor Therapeutics, Inc. (CAPR) — deramiocel
Duchenne muscular dystrophy
Nov 22, 2026 — Capricor (CAPR): FDA PDUFA target action date for deramiocel's biologics application in Duchenne muscular dystrophy. The sponsor submitted a major amendment and requested review of a refined proposed indication focused on upper-limb function. FDA outcome pending.
Last verified Oct 30, 2026
Request a catalyst readSavara Inc (SVRA) — MOLBREEVI
autoimmune pulmonary alveolar proteinosis
Nov 22, 2026 — Savara (SVRA): FDA PDUFA target action date for the molgramostim (MOLBREEVI) biologics license application in autoimmune pulmonary alveolar proteinosis (aPAP). FDA outcome pending.
Last verified Oct 30, 2026
Request a catalyst readBridgeBio Pharma, Inc. (BBIO) — ribitol (BBP-418)
Limbgirdle muscular dystrophy 2I
Nov 27, 2026 — BridgeBio (BBIO): FDA PDUFA target action date for ribitol (BBP-418) in limb-girdle muscular dystrophy 2I. FDA outcome pending.
Last verified Oct 30, 2026
Request a catalyst readDeciphera/Ono — tirabrutinib
Relapsed or refractory primary central nervous system lymphoma
Dec 18, 2026 — Deciphera/Ono: FDA PDUFA target action date for the tirabrutinib New Drug Application seeking accelerated approval in relapsed or refractory primary central nervous system lymphoma. FDA outcome pending.
Last verified Oct 24, 2026
Request a catalyst readDeciphera/Ono (ONPH) — tirabrutinib
Relapsed or refractory primary central nervous system lymphoma
Dec 18, 2026 — Deciphera/Ono: FDA PDUFA target action date for the tirabrutinib New Drug Application seeking accelerated approval in relapsed or refractory primary central nervous system lymphoma. FDA outcome pending.
Last verified Oct 30, 2026
Request a catalyst readPraxis Precision Medicines (PRAX) — relutrigine
SCN2A and SCN8A developmental epileptic encephalopathies
Dec 27, 2026 — Praxis (PRAX): FDA PDUFA target action date for the relutrigine New Drug Application in SCN2A and SCN8A developmental epileptic encephalopathies (DEEs). FDA outcome pending.
Last verified Oct 30, 2026
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