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  • Simantini Singh Deo

Novavax Gains FDA Approval for NUVAXOVID with Narrowed Indication Covering High-Risk Populations
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Sarepta Therapeutics Gains Revised ELEVIDYS Indication After FDA Adds Boxed Warning for Acute Liver Failure

Simantini Singh Deo

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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

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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

Pharma Now

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

Pharma Now

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.

Pharma Now