FDA cautions that it may only be able to give the green light for booster shots later this month to those vaccinated with the Pfizer/BioNTech Covid-19...
Federal Register notice: A 10/28 advisory committee discusses whether an accelerated approval for an Oncopeptides NDA for Pepaxto (melphalan flufenami...
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.
