concerns
Roche Halts Elevidys Distribution in Several Countries Following Sarepta and FDA Safety Concerns
Roche; Sarepta Therapeutics; Elevidys; Duchenne muscular dystrophy; gene therapy; FDA; shipment halt; safety concerns; patient deaths
Sarepta Halts US Shipments of Duchenne Therapy Elevidys After FDA Pressure
Sarepta Therapeutics; Elevidys; Duchenne muscular dystrophy (DMD); FDA; gene therapy; safety concerns; shipment suspension; patient deaths
Sarepta Stands Behind Elevidys After FDA Requests Withdrawal Amid Safety Concerns
Sarepta; Elevidys; FDA; gene therapy; market withdrawal; safety concerns; Duchenne muscular dystrophy; deaths; clinical trial hold
FDA Advisory Panel Rejects GSK’s Blenrep in New Combinations Over Safety, Efficacy Concerns
Blenrep; GSK; FDA Advisory Panel; multiple myeloma; ocular toxicity; safety concerns; DREAMM trials; drug approval; relapsed or refractory multiple myeloma
EU Lifts Restriction on Valneva’s Chikungunya Vaccine for Older Adults, Recommends Caution
Valneva; Chikungunya vaccine; IXCHIQ; European Medicines Agency; older adults; safety concerns; label extension; adverse events
Novavax Approval Process Raises Concerns Among Former Regulators About FDA Integrity
Novavax; FDA approval; COVID-19 vaccine; regulatory process; integrity concerns; delays; political interference
FDA, CDC call for pause of chikungunya shot rollout in older adults
Ixchiq vaccine, chikungunya, safety concerns, older adults, FDA, CDC, pause recommendation, adverse events
MacroGenics Discontinues Development of Vobra Duo ADC After Phase 2 Prostate Cancer Trial Results
MacroGenics, vobra duo, antibody-drug conjugate, B7-H3, prostate cancer, TAMARACK trial, discontinued development, safety concerns
Drugmakers renew concerns over UK’s attractiveness for investment
Investments, UK, UK ‘s, concerns, Industry, attractiveness
Pliant Therapeutics Discontinues Phase 2b/3 Trial of Bexotegrast in Idiopathic Pulmonary Fibrosis Due to Safety Concerns
Pliant Therapeutics, bexotegrast, BEACON-IPF trial, idiopathic pulmonary fibrosis (IPF), safety concerns, clinical trial discontinuation