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...
After FDA commissioner Stephen Hahn assured Congress that FDAs review and approval/authorization of a Covid-19 vaccine would be based on data and scie...
FDA releases the FDA-483 with three observations from an inspection at Front Range Laboratories.