HHS restores FDAs authority to issues regulations without HHS authority, which was removed late in the Trump Administration.
FDA accepts for review a Supernus Pharmaceuticals supplemental NDA for Qelbree (viloxazine extended-release capsules) for treating attention-deficit h...
FDA clears a Molekule 510(k) for its existing air purifier, Air Pro, classifying it as a Class 2 medical device for medical use for the destruction of...
CDER Office of Generic Drugs reaches the milestone of approving more than 100 generic drug applications with a Competitive Generic Therapy designation...
FDA announces a 9/17 Vaccines and Related Biological Products Advisory Committee meeting to discuss Pfizer-BioNTechs supplemental BLA seeking approval...
FDA approves Janssens Invega Hafyera six-month atypical antipsychotic injection for some adult schizophrenia patients.
FDA posts a Federal Register notice of its intent to not approve an Intarcia NDA for a diabetes drug/device combination product.
Federal Register notice: FDA sends to OMB an information collection revision entitled Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Fa...