After determining inadequate recall notifications to date, FDA issues a rare Section 518(a) notification order to Philips Respironics requiring the co...
FDA removes an Immunome clinical hold on its antibody cocktail (IMM-BCP-01) for treating Covid-19 after the company provided more therapy preparation ...
A federal judge sentences James Boccuzzi of Parkland, FL, a former sales director for Blackstone Labs, to 51 months in prison for conspiring to defrau...
Federal Register notice: FDA classifies the interoperable automated glycemic controller into medical device Class 2 (special controls).
FDA releases a five-page Form FDA-483 issued to Leesar Inc. following a 10/2021 inspection of the Fort Myers, FL outsourcing facility.
Allogene Therapeutics receives an FDA fast track designation for its allogeneic CAR T product (ALLO-316) for treating patients with advanced or metast...
FDA issues a warning against using ACON Biotech Covid-19 tests due to false results concerns.
Venatorx Pharmaceuticals plans a fourth quarter NDA submission following positive results from its pivotal Phase 3 study evaluating cefepime-taniborba...