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Novavax Gains FDA Approval for NUVAXOVID with Narrowed Indication Covering High-Risk Populations
FDA has narrowed NUVAXOVID's indication to adults 65+ and high-risk individuals aged 12–64, reflecting evolving COVID-19 vaccine risk-benefit standards.
Simantini Singh Deo
Sarepta Therapeutics Gains Revised ELEVIDYS Indication After FDA Adds Boxed Warning for Acute Liver Failure
FDA added a boxed warning for acute liver failure to ELEVIDYS and restricted its use to ambulatory DMD patients following post-market deaths.
Simantini Singh Deo
Teva Acquires Emalex Biosciences for $700M to Advance Ecopipam NDA in Pediatric Tourette Syndrome
Teva closes $700M Emalex acquisition, targeting an H2 2026 NDA submission for ecopipam in pediatric Tourette syndrome.
Simantini Singh Deo
Axplora Consolidates Global UDCA API Manufacturing at India's Vizag Facility After European Exit
Axplora exits Italian UDCA production, consolidating global API supply at its GMP-certified Vizag facility with capacity and sustainability gains.
Vaibhavi M.
