Gilead Sciences agrees to pay $202 million to resolve claims that the company offered and paid kickbacks (e.g., honoraria payments, meals, and travel ...
FDA commissioner Marty Makary suggests more data could be required for Covid-19 vaccine boosters this winter.
A poll from the Harvard University T.H. Chan School of Public Health finds that more Americans say they will be trusting public health agencies less i...
Skadden attorneys say the FDA reduction in force should have the greatest negative impact on products that are in development.
FDA warns Marietta, GA-based Cosco International about CGMP violations in its production of unapproved and misbranded drugs.
A group of bipartisan House lawmakers introduce the No Handouts for Drug Advertisements Act, a bill that would prohibit tax deductions for the annual ...
FDA misses a 4/29 user fee review action extension on a Stealth BioTherapeutics NDA for elamipretide, a first-in-class mitochondria-targeted therapeut...
FDA warns Amazon it is marketing unapproved and misbranded external analgesic drug products for use before sensitive cosmetic procedures.