Tag Archives: Approves

FDA Approves Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for Cystic Fibrosis Patients Ages 12 and Older Who Have at Least One F508del Mutation

FDA Approves Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for Cystic Fibrosis Patients Ages 12 and Older Who Have at Least One F508del Mutation Print this page BOSTON–(BUSINESS WIRE)–Oct. 21, 2019– Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has approved Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of cystic fibrosis (CF)… Read More »

FDA Approves Otezla (apremilast) for the Treatment of Oral Ulcers Associated with Behçet’s Disease

Print this page SUMMIT, N.J.–(BUSINESS WIRE) July 19, 2019 — Celgene Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved Otezla (apremilast) 30 mg twice daily (BID) for the treatment of adult patients with oral ulcers associated with Behçet’s Disease. Otezla, an oral, selective inhibitor of phosphodiesterase 4 (PDE4), is the… Read More »

FDA Approves Expanded Monotherapy Label for Merck’s Keytruda (pembrolizumab) for First-Line Treatment of NSCLC

Print this page KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not… Read More »

FDA Approves Balversa (erdafitinib) for the Treatment of Metastatic Bladder Cancer

FDA Approves Balversa (erdafitinib) for the Treatment of Metastatic Bladder Cancer Print this page April 12, 2019 — The U.S. Food and Drug Administration today granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or… Read More »

US approves first postpartum depression drug

The U.S. Food and Drug Administration has approved the first drug specifically developed for severe depression after childbirth. The agency on Tuesday approved Sage Therapeutics’ Zulresso, an IV drug given over two and a half days. Sage said Zulresso will cost $ 34,000 without insurance, plus costs for staying in a hospital or infusion center.… Read More »