Pfizer says it and BioNTech will request an FDA emergency use authorization for a Covid vaccine booster shot for children ages 5-11.
FDA publishes a guidance to help sponsors submit bioavailability information for specified drug products in INDs and NDAs.
Federal Register notice: FDA makes available a draft guidance entitled Diversity Plans to Improve Enrollment of Participants from Underrepresented Rac...
A California appeals court upholds $302 million of a $344 million trial court judgment against Ethicon over misleading communications about its pelvic...
FDA tells Protagonist Therapeutics that it intends to rescind the companys breakthrough therapy designation for rusfertide and its use in treating pol...
FDA grants Merck a breakthrough therapy designation for V116, an investigational 21-valent pneumococcal conjugate vaccine.
AbbVie and Genmab say they will open regulatory discussions on their investigational cancer drug epcoritamab, based on Phase 1/2 trial topline results...
FDA publishes a draft guidance updating a 2016 guidance by telling medical product sponsors what should be included in a Race and Ethnicity Diversity ...