FDAs Oncology Center of Excellence 2020 annual report describes the work it performed on behalf of cancer patients during a Covid-19 pandemic year.
FDA clears a B-Secur 510(k) for its HeartKey software library, which was developed to enable scalability of medical grade EKG/ECG across Internet of T...
A decade-old, FDA-investigated case involving the unlicensed wholesale distribution of prescription drugs by Israeli citizen Boaz BenMoshe moves to se...
FDA says initial safety trial results show a higher risk of serious heart events and cancer in patients taking Pfizers Xeljanz for rheumatoid arthriti...
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...