A decade-old, FDA-investigated case involving the unlicensed wholesale distribution of prescription drugs by Israeli citizen Boaz BenMoshe moves to se...
FDA approves a Durect NDA for Posimir (bupivacaine solution) for infiltration use in adults for administration into the subacromial space under direct...
FDA plans a 3/29-30 public workshop on Nitrosamines as Impurities in Drugs; Health Risk Assessment and Mitigation.
FDA releases safety-related labeling changes for Adamas Gocovri.
FDA approves a BioCryst Pharmaceuticals supplemental NDA for Rapivab (peramivir injection) expanding the patient population for treating acute uncompl...
Drug consulting firm Indegene says many doctors are voicing concerns about their virtual interactions with drug company representatives forced by the ...
FDA releases an FDA-483 with two observations issued following an inspection at Hopkinton Drug, a producer of non-sterile drug products.
FDA releases summaries from three PDUFA 7 workgroup and subgroup discussions at the end of 2020.