Posts

FDA hearing on psychedelic approval centers on access and safety

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FDA clears Curium’s BEXLUTRY, a Lutathera-equivalent radioligand therapy

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FDA launches pilot to accelerate Phase 1 drug trials

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Scholar Rock wins FDA approval for ISEMBYLD SMA therapy after year-long manufacturing delay

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Scholar Rock wins FDA approval for ISEMBYLD, a muscle-targeted SMA treatment

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FDA Reassesses Rare-Disease Trial Standards and Endpoint Selection

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FDA delays decision on Exelixis colorectal-cancer drug to March 2027

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FDA Places Partial Hold on Biohaven’s Epilepsy Drug After $350 Million Licensing Deal

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FDA expands Bayer’s Hyrnuo into first-line HER2-mutant lung cancer

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FDA signals flexibility on psychedelic drug review while keeping evidence standards

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FDA makes acting CBER and CDER leaders permanent

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FDA Makes CDER and CBER Leadership Permanent While Commissioner Nominee Awaits Senate Confirmation

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ARPA-H funds companies and research teams to build AI tools for heart disease

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Pharvaris stock jumps after pivotal Phase 3 success in hereditary angioedema

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Inhibitor Therapeutics reports clinical, regulatory, formulation and legal progress

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FDA approves AstraZeneca’s oral SERD camizestrant despite negative advisory-panel vote

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Ionis wins first-ever FDA approval for Alexander disease therapy

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FDA files show lingering concerns and split views over Replimune’s melanoma drug

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Ivonescimab’s Keytruda win raises the stakes for regulatory review and global adoption

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ARPA-H commits up to $125 million to on-demand personalized RNA medicines

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