FDA releases its latest batch of Warning Letters that includes one medical product company McKesson.
FDA clears a LaserOptek 510(k) for its PicoLO picosecond Nd:YAG for use in dermatology and general and plastic surgery.
FDA grants Amplyx Pharmaceuticals an orphan drug designation for APX001 and its use for treating cryptococcosis.
FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), its anti-PD-1 therapy as monotherapy or in combination with pla...
Federal Register notice: FDA has determined that the regulatory review period for Sareptas Duchenne drug Exondys 51 (eteplirsen).
FDA says it is working on a new plan to modernize dietary supplement regulation and oversight.
FDAs Office of Criminal Investigations helps investigate a case where a Texas marketer agreed to pay the government $339,413 for allegedly accepting i...
Federal Register notice: FDA announces a 3/18 workshop entitled Enhancing the Incorporation of Patient Perspectives on Clinical Trials, which is being...