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FDA publishes a draft guidance updating a 2016 guidance by telling medical product sponsors what should be included in a Race and Ethnicity Diversity ...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FDA publishes a draft guidance to help ANDA applicants prepare and submit pH adjuster waiver requests for specific types of drugs.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.
Federal Register notice: FDA makes available two final device-specific guidance documents for the Safety and Performance Based Pathway.