Sangamo Therapeutics begins a rolling BLA submission seeking accelerated approval of its experimental Fabry disease gene therapy, following results fr...
Bayer reports that its investigational oral anticoagulant asundexian reduced the risk of recurrent ischemic stroke by 26% in patients who had recently...
A PDUFA 8 negotiating subgroup reviews industrys counterproposal to FDAs facility lifecycle proposal.
Reuters reports exclusively that the telehealth firm Hims and Hers Health is selling GLP-1 pills for $100 less per month than the branded version offe...
Johnson & Johnson MedTech recalls multiple versions of its Cerepak Detachable Coil System, which are used to treat intracranial aneurysms and other ne...
FDA updates the safety labeling for the widely used chemotherapy drugs capecitabine (Genentechs Xeloda) and fluorouracil (multiple manufacturers) to s...
FDA publishes a guidance with recommendations on computer software assurance for computers and automated data processing systems used as part of medic...
President Trump signs a government spending bill that officially reinstates FDAs Rare Pediatric Disease Priority Review Voucher program.
