Tag Archives: Approves

FDA Approves Vitrakvi (larotrectinib) for TRK Fusion Cancers

FDA Approves Vitrakvi (larotrectinib) for TRK Fusion Cancers Print this page November 26, 2018 — The U.S. Food and Drug Administration today granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker). This is the second time the agency has approved a cancer treatment… Read More »

FDA Approves Yupelri (revefenacin) for Chronic Obstructive Pulmonary Disease (COPD)

FDA Approves Yupelri (revefenacin) for Chronic Obstructive Pulmonary Disease (COPD) Print this page DUBLIN, Ireland, HERTFORDSHIRE, England and PITTSBURGH, Nov. 9, 2018 /PRNewswire/ — Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance Biopharma”) and Mylan N.V. (NASDAQ: MYL) (“Mylan”) today announced that the U.S. Food and Drug Administration (FDA) has approved the  New Drug Application (NDA) for… Read More »

FDA Approves Newly Formulated OTC Primatene Mist (epinephrine) to Treat Mild Asthma

Print this page RANCHO CUCAMONGA, Calif., Nov. 07, 2018 (GLOBE NEWSWIRE) — Amphastar Pharmaceuticals, Inc., (NASDAQ: AMPH) announced today that the U.S. Food and Drug Administration (FDA) granted approval of its New Drug Application (NDA) for Primatene Mist (epinephrine inhalation aerosol bronchodilator suspension), which is delivered by a metered dose inhaler (MDI) with a non-chlorofluorocarbon… Read More »