Tag: FDA Approval
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Regeneron Wins FDA Approval for Pasatru in Ultra-Rare Bone Disease
The FDA approved Regeneron’s Pasatru for adults with fibrodysplasia ossificans progressiva after Phase 3 data showed a 90–94% reduction in new heterotopic ossification lesions versus placebo.
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Bristol Myers Squibb (BMS) Wins FDA Approval for the First CELMoD Therapy in Multiple Myeloma
The FDA granted accelerated approval to Bristol Myers Squibb’s Zenbexus (iberdomide) as part of a three-drug regimen for previously treated multiple myeloma, marking the first approval of a CELMoD therapy.
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Moderna Wins FDA Approval for the First mRNA Flu Vaccine
FDA approval of Moderna’s mFlusiva marks the first U.S. approval of an mRNA flu vaccine and expands the platform beyond COVID-19.