Bristol Myers Squibb says an Opdivo (nivolumab) Phase 3 trial in patients post-surgery with high-risk, muscle-invasive urothelial carcinoma met its pr...
Federal Register notice: FDA makes available three final guidance documents for its Accreditation Scheme for Conformity Assessment Pilot Program.
FDA approves Vertex Pharmaceuticals Kalydeco (ivacaftor) for use in certain children with cystic fibrosis ages four months to less than six months old...
FDA approves GlaxoSmithKlines Nucala (mepolizumab) for adults and children aged 12 years and older with hypereosinophilic syndrome for six months or l...
FDA grants RemeGen a Breakthrough Therapy designation for disitamab vedotin (RC48), an anti-HER2 antibody drug conjugate for second-line treatment of ...
FDA publishes three guidances implementing the voluntary pilot for the Accreditation Scheme for Conformity Assessment.
The House Oversight and Reform Committee schedules two days of hearings on drug prices with testimony from executives of six companies.
Federal Register notice: FDA proposes to withdraw approval of five ANDAs because the application holders have repeatedly failed to file required annua...