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Apr 23, 2026
January and March 2026 drug pipeline updates included Phase 3 results, Fast Track designations and Priority Review decisions across multiple disease areas. Mavacamten, teplizumab-mzwv, anifrolumab, AXS-05, gedatolisib and AFTX-201 were among the programs with notable milestones.
Mar 05, 2026
Protagonist Therapeutics reported fourth quarter and full year 2025 financial results, with two NDAs submitted and multiple Phase 3 trials advancing. The company holds $646 million in cash and expects regulatory decisions in 2026.
Feb 16, 2026
The FDA is set to announce decisions in March 2026 on several drug applications, including label expansions for approved therapies and new drug candidates, with some making repeat approval attempts.
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.
