Avenzo Therapeutics Granted Fast Track Designation for AVZO-1418, a Potential Best-in-Class EGFR/HER3 Bispecific Antibody-Drug Conjugate, for the Treatment of Patients with EGFR-Mutated TKI-Pretreated ...

– Second and third FDA Fast Track Designations for CABA-201, following the systemic lupus erythematosus (SLE) and lupus nephritis (LN) designation, providing the opportunity for expedited development ...

Haifa, ISRAEL, June 30, 2025 (GLOBE NEWSWIRE) -- Minovia Therapeutics Ltd. (“Minovia” or the “Company”), a clinical-stage biotechnology company developing novel therapies to treat mitochondrial ...

MNV-201, a mitochondrial cell therapy, received FDA fast track designation for myelodysplastic syndrome, highlighting its potential to address mitochondrial dysfunction in this serious blood disorder.

NEW YORK--(BUSINESS WIRE)--Schrödinger, Inc. (Nasdaq: SDGR) today announced that SGR-1505, its clinical stage MALT1 inhibitor, was designated as a Fast Track product by the U.S. Food and Drug ...

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced its expanded access policy for NRX-100 (preservative-free ketamine) after receiving FDA Fast Track designation ...

– SGT-212 has been granted FDA Rare Pediatric Disease and Fast Track designations – – SGT-212 is the only dual route gene therapy in development to treat Friedreich’s ataxia – – FALCON Phase 1b ...

Incannex Healthcare received fast track designation from the Food and Drug Administration for its IHL-42X treatment of obstructive sleep apnea. The designation grants the IHL-42X program more frequent ...

Adagene Inc. ADAG announced that the FDA has granted Fast Track designation to its lead clinical-stage immuno-oncology candidate, muzastotug (ADG126). The designation was granted to muzastotug in ...

NEW YORK, March 27 (Reuters) - Drug maker Nuvelo Inc. on Tuesday said it has been granted two separate fast-track designations by the U.S. Food and Drug Administration (FDA) for its cancer drug, ...