FDA approves an expanded indication for Medtronics Freezor Xtra Cryoablation Catheter treating patients with atrioventricular nodal re-entrant tachyc...
Faced with a backlash over its $89,000 annual price for a decades-old steroidal drug that was recently approved for treating Duchenne muscular dystrop...
FDA approves a Valeant Pharmaceuticals NDA for Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis.
Federal Register Notice: FDA announces an amendment to a 3/6-7 Pediatric Advisory Committee that outlines two products that will undergo a safety revi...
FDA approves a Hologic PMA for its hepatitis C virus (HCV) assay for quantitation of HCV viral load and confirming active HCV infection on the fully a...
Public Citizen says a bill introduced by Rep. DeLauro would authorize FDA to order emergency recalls of dangerous drugs.
AdvaMed praises S. 404 that it says will modernize the FDA medical device inspection process.
FDA expands the approval for Boehringer Ingelheim Pharmaceuticals asthma medication Spiriva Respimat for the long-term, once-daily maintenance treatme...