FDA warns Chinas Unimicro Medical Systems about multiple serious violations of Quality System regulations in its production of pneumoperitoneum needle...
Federal Register notice: FDA plans a 4/6 advisory committee meeting to discuss considerations for use of Covid19 vaccine booster doses.
Federal Register notice: FDA debars Irfanali Nisarali Momin for five years from importing or offering for import any drug into the U.S.
FDA denies a BioDelivery Sciences petition seeking agency actions to restrict follow-on products citing Belbuca as the reference-listed drug.
The American Medical Association bestows its Award for Outstanding Government Service on CBER director Peter Marks for his Covid-19 leadership efforts...
Federal Register notice: FDA updates its current listing of medical devices that have received an Emergency Use Authorization during the Covid-19 pand...
Provention Bio refiles its BLA for teplizumab for the delay of clinical Type 1 diabetes in at-risk individuals.
FDA approves Bristol-Myers Squibbs Opdualag to treat some adults and pediatric patients with melanoma.