Moderna says it will seek FDA emergency use authorization for its Covid-19 vaccine in infants 6 months to under 6 years old.
Pfizer recalls branded and authorized generic lots of Accuretic tablets due to the presence of a nitrosamine above the acceptable daily level.
FDA warns Fort Lauderdale, FL-based ECI Pharmaceuticals about listing violations for two estrogen products that have been removed from the agencys onl...
Federal Register notice: FDA announces an Emergency Use Authorization issuance to Eli Lilly for bebtelovimab and its use in treating mild-to-moderate ...
FDA publishes an immediately effective guidance to tell how it is handling ophthalmic dispensers packaged with their drugs in light of an appeals cour...
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.