FDA grants Fast Track designation to Coya Therapeutics' COYA 302 for ALS
The FDA granted Fast Track designation to COYA 302 for ALS. Phase 1 data showed tolerability and biomarker effects, and the phase 2 ALSTARS trial is underway.
selective co-stimulation modulator
MechanismRelated News
FDA Accepts NDAs for Beren's Adrabetadex and Dr. Reddy's Abatacept Biosimilar
The FDA has accepted for review Beren Therapeutics' NDA for adrabetadex in infantile-onset Niemann-Pick disease type C with a PDUFA date of August 17, 2026, and Dr. Reddy's BLA for a biosimilar to Orencia (abatacept).
FDA Accepts Dr Reddy's Application for Orencia Biosimilar DRL-AB
The US FDA has accepted Dr Reddy's Biologics License Application for DRL-AB, a proposed interchangeable biosimilar to Orencia (abatacept) for intravenous infusion, marking the first abatacept biosimilar submission.
FDA Accepts Dr. Reddy's BLA for Proposed Interchangeable Abatacept Biosimilar
The FDA has accepted Dr. Reddy's Laboratories' BLA for DRL_AB, a proposed interchangeable biosimilar to abatacept, submitted in December 2025. The application is the first for an abatacept biosimilar and is supported by Phase 1 data showing pharmacokinetic similarity.