fda-and-biotech News
Sarepta Gains FDA Nod for Study to De-Risk Key Gene Therapy Elevidys
Company to test new drug regimen aimed at mitigating severe liver injury risk that prompted an FDA black box warning and restricted the drug's use.
Amgen Shares Climb on Landmark Repatha Trial Data
Phase 3 study shows the cholesterol drug cut the risk of first-time major cardiovascular events by 25%, bolstering its market position.
Teva Shares Climb on European Approval for Biosimilars
The approvals for PONLIMSI and DEGEVMA position Teva to challenge Amgen's $6.6 billion bone disease franchise, marking a key win for its growth strategy.
Anavex Stock Plunges on European Setback for Alzheimer's Drug
Company confirms negative regulatory signal for its lead drug blarcamesine, overshadowing a narrower Q4 loss and sparking analyst downgrades.
Mesoblast Shares Climb on Strong Ryoncil Sales Forecast
Company projects over 37% sequential quarterly growth for its recently approved cell therapy, signaling a robust commercial launch in the U.S. market.
Novartis Wins FDA Nod for SMA Gene Therapy in Older Patients
Approval for Itvisma, a new formulation of Zolgensma, positions the one-time treatment to directly challenge chronic therapies from Biogen and Roche.
Novo Nordisk Shares Tumble After Alzheimer's Drug Trial Fails
The setback dashes hopes for expanding the blockbuster GLP-1 drug semaglutide into a major new therapeutic area, prompting an analyst downgrade.
Nuvation Bio CSO Sells Entire Stake After Drug Data Fuels 75% Rally
Chief Scientific Officer liquidates $2.7 million in shares as stock hits 52-week high on positive clinical trial results, raising questions of a near-term peak.