Tag Archives: Approves

FDA Approves Nourianz (istradefylline) as an Add-On Drug to Treat Off Episodes in Adults with Parkinson’s Disease

FDA Approves Nourianz (istradefylline) as an Add-On Drug to Treat Off Episodes in Adults with Parkinson’s Disease Print this page TOKYO–(BUSINESS WIRE)– August 28, 2019 — Kyowa Kirin Co., Ltd., (Kyowa Kirin, TYO: 4151) announces today that the U.S. Food and Drug Administration (FDA) has granted approval for Nourianz (istradefylline) for use as adjunctive treatment… Read More »

In Brief: FDA Approves New Drug to Improve Sexual Desire in Women

The Food and Drug Administration (FDA) has approved a new drug for the treatment of hypoactive sexual desire disorder in premenopausal women.  Bremelanotide (to be marketed as Vyleesi) is used on-demand. Bremelanotide is a peptide which acts as a melanocortin receptor agonist.  Its mechanism of action is distinct from flibanserin and is thought to have… Read More »

FDA Approves Dovato (dolutegravir/lamivudine) for HIV-1 Infection

FDA Approves Dovato (dolutegravir/lamivudine) for HIV-1 Infection Print this page LONDON–(BUSINESS WIRE) April 08, 2019 –ViiV Healthcare today announced that the US Food and Drug Administration (FDA) approved Dovato, a complete, once-daily, single-tablet regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg for the treatment of HIV-1 infection in adults with no antiretroviral… 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 »