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FDA publishes a draft guidance updating a 2016 guidance by telling medical product sponsors what should be included in a Race and Ethnicity Diversity ...
The House Committee on Oversight and Reform issues a report demonstrating McKinsey & Companys conflicts of interest in working for opioid manufacturer...
FDA publishes a draft guidance to help ANDA applicants prepare and submit pH adjuster waiver requests for specific types of drugs.
Federal Register notice: FDA announces a 6/9-10 Cellular, Tissue and Gene Therapies Advisory Committee meeting to discuss two bluebird bio BLAs.