News Related to FDA

Related coverage linked through entity extraction aliases.

FDA Accepts Dr. Reddy's Application for Orencia Biosimilar

Feb 21, 2026

Dr. Reddy's Laboratories has received FDA acceptance for its biosimilar application targeting Bristol-Myers Squibb's Orencia, marking the first U.S. application for an off-patent version of the arthritis treatment that generated $2.7 billion in 2025.

CRISPR Therapeutics Positioned for Growth as Casgevy Sales Rise

Feb 20, 2026

Switzerland-based CRISPR Therapeutics stands to benefit from increased Casgevy sales following partner Vertex Pharmaceuticals' fourth-quarter results, with five additional gene-editing therapies in clinical trials targeting larger patient populations.

FDA Accepts Roche's Giredestrant Filing for ESR1-Mutated Breast Cancer

Feb 20, 2026

The FDA has accepted Roche's new drug application for oral SERD giredestrant in ESR1-mutated, ER-positive advanced breast cancer, with a decision expected by December 18, 2026. The filing is restricted to the ESR1-mutant population despite phase 3 trial benefits in broader patients.

FDA Clears FOXG1 Gene Therapy FRF-001 for Clinical Trials

Feb 16, 2026

The U.S. Food and Drug Administration has approved an Investigational New Drug application for FRF-001, a viral gene therapy for FOXG1 syndrome developed at the University at Buffalo. The first-in-human trial will be independently sponsored by the FOXG1 Research Foundation.