Regulatory & Policy
Ocugen's gene therapy gets FDA RMAT for geographic atrophy
Ocugen, Inc. (Nasdaq: OCGN), a Malvern, Pennsylvania-based biotechnology company, announced that the US FDA has granted Regenerative Medicine Advanced...
J&J's Rybrevant Faspro gains priority review for head and neck cancer after immunotherapy failure
Johnson & Johnson (NYSE: JNJ) announced that the US FDA has granted Priority Review to the supplemental Biologics License Application (sBLA) for amivantamab...
EU approves Datroway as first TROP2 ADC with OS benefit in first-line metastatic TNBC
The European Commission has approved Datroway (datopotamab deruxtecan) as monotherapy for the 1st-line treatment of adult patients with unresectable or...
Karyopharm to file myelofibrosis sNDA after FDA backs SVR35 surrogate endpoint
Karyopharm Therapeutics Inc. (Nasdaq: KPTI), headquartered in Newton, Massachusetts, announced plans to submit a supplemental New Drug Application (sNDA) to...
FDA grants Aspen RMAT designation for cell therapy in Parkinson's disease
San Diego-based Aspen Neuroscience, Inc. announced receipt of US FDA Regenerative Medicine Advanced Therapy (RMAT) designation for sasineprocel (ANPD001),...
Sumitomo's enzomenib gets FDA orphan drug designation for ALL
Marlborough, Massachusetts-based Sumitomo Pharma America, Inc. (SMPA) has secured US FDA orphan drug designation for enzomenib (DSP-5336) in acute...
FDA advisory committee votes against Capricor's deramiocel effectiveness for DMD cardiomyopathy
The US FDA's Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) voted 9 to 3 against the effectiveness of deramiocel (CAP-1002) for the...
FDA AdCom briefing raises broad efficacy concerns over Replimune's melanoma BLA
The US FDA's Cellular, Tissue, and Gene Therapies Advisory Committee convenes on July 30 to publicly deliberate on Replimune's (Nasdaq: REPL) BLA 125827 for...
AbelZeta wins FDA clearance for registrational Phase II study of lupus nephritis CAR-T
Rockville, Maryland-based AbelZeta Pharma has received US FDA clearance to proceed with a multi-center registrational Phase II trial of C-CAR168, an...
FDA briefing casts doubt on Capricor's deramiocel ahead of DMD advisory committee
San Diego-based Capricor Therapeutics (Nasdaq: CAPR) faces a critical regulatory test on Tuesday when the US FDA's Cellular, Tissue, and Gene Therapies...
CHMP recommends Gilead's Trodelvy plus Keytruda for PD-L1-positive mTNBC
Sacituzumab govitecan (Trodelvy) in combination with pembrolizumab (Keytruda) has received a CHMP positive opinion for first-line treatment of...
CHMP recommends EU approval of Roche's Susvimo for nAMD
Roche (SWX: ROG) has secured a positive CHMP recommendation for Susvimo (ranibizumab injection) 100 mg/mL for neovascular age-related macular degeneration,...
CHMP backs leriglitazone for early-stage cerebral adrenoleukodystrophy in children
Leriglitazone (NEZGLYAL) has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, positioning it...
Icotyde gains CHMP backing as first oral IL-23 receptor antagonist for plaque psoriasis
The European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion for Icotyde (icotrokinra) as a plaque psoriasis...
Sanofi abandons amlitelimab in atopic dermatitis despite positive Phase III data
Sanofi (Nasdaq: SNY) announced on July 24, 2026 that it will not submit amlitelimab (SAR445229, KY1005), its OX40-ligand monoclonal antibody, for regulatory...
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