FDA grants Fast Track designation to Coya Therapeutics' COYA 302 for ALS
May 19, 2026
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.
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May 19, 2026
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.
Feb 21, 2026
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.
Feb 23, 2026
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).
Feb 21, 2026
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.