GSK reports favorable overall survival and progression-free survival data in a Phase 3 trial involving Jemperli (dostarlimab) in adult patients with p...
A 2/29-completed FDA inspection of Eugia SEZ Private Ltd.s Telangana, India sterile drug manufacturing facility results in a seven-item Form FDA 483.
Federal Register notice: FDA withdraws the approval of Bayers NDA for Aliqopa (copanlisib) in response to a failed confirmatory trial.
FDA posts a final guidance entitled Controlled Correspondence Related to Generic Drug Development.
FDA approves an Orchard Therapeutics BLA for Lenmeldy (atidarsagene autotemcel), a one-time, single-dose gene therapy indicated for treating children ...
Sleepnet recalls its CPAP and BIPAP sleep apnea masks with magnets due to potential interference with certain medical devices.
FDA launches a new Web page to highlight how it uses inspections to help ensure drug safety and quality.
FDA provides additional information through a just-posted question-and-answer document about its new Quality Manufacturing Maturity Prototype Assessm...
