Pfizer pauses enrollment in a registration-enabling Phase 2 study of elranatamab after FDA requested additional data on three cases of peripheral neur...
ViiV Healthcare begins a rolling NDA submission for cabotegravir, a long-acting, injectable drug for preventing HIV.
Stryker petitions FDA to exempt powered patient transport from 510(k) premarket notification.
Siga Technologies files an NDA for Tpoxx (tecovirimat), an intravenous formulation for treating human smallpox disease in adults and pediatric patient...
FDA warns Unived it is marketing misbranded unapproved new drugs.
FDA warns Immune & Genetics Protocols that it is marketing a misbranded unapproved new drug.
FDA announces a 6/10 virtual public workshop on orthopedic device postmarket programs and activities.
Office of Generic Drugs Research and Standards director Robert Lionberger says FDA is taking many steps to promote the development of complex generic ...