Former FDA chief counsel Peter Barton Hutt passes away at the age of 91.
Boston Scientific recalls all unused spinal cord stimulator Infinion CX Leads after determining that the lead body may experience mechanical stress at...
CDRH issues an early alert based on a Draeger letter to customers recommending certain VentStar Resus Neo hoses (breathing circuits) be removed.
AbbVie announces positive topline results from the Phase 3 CERVINO study evaluating etentamig in patients with triple-class exposed relapsed/refractor...
FDA warns Indias Shoolin Pharma Chem that it is producing active pharmaceutical ingredients in insanitary conditions and with significant CGMP deviati...
FDA orders a Boxed Warning for American Regents Injectafer (ferric carboxymaltose injection) over the risk of symptomatic hypophosphatemia.
Following a course reversal by FDA, uniQure files a BLA seeking accelerated approval of ifezuntirgene inilparvovec (AMT-130), an investigational gene ...
CDRH issues an alert on AVID Medical convenience kits based on a letter the company sent to customers recommending that certain kits be corrected prio...
