Tag Archives: Approves

FDA Approves Gimoti (metoclopramide) Nasal Spray for Diabetic Gastroparesis

FDA Approves Gimoti (metoclopramide) Nasal Spray for Diabetic Gastroparesis Print this page SOLANA BEACH, Calif., June 19, 2020 (GLOBE NEWSWIRE) — Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for… Read More »

FDA Approves First Generic of Proventil HFA Metered Dose Inhaler to Treat and Prevent Bronchospasm

April 08, 2020 — The U.S. Food and Drug Administration today approved the first generic of Proventil HFA (albuterol sulfate) Metered Dose Inhaler, 90 mcg/Inhalation, for the treatment or prevention of bronchospasm in patients four years of age and older who have reversible obstructive airway disease, as well as the prevention of exercise-induced bronchospasm in… Read More »

FDA Approves Dayvigo (lemborexant) for the Treatment of Insomnia in Adult Patients

FDA Approves Dayvigo (lemborexant) for the Treatment of Insomnia in Adult Patients Print this page December 23, 2019 — Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) today announced that the U.S. Food and Drug Administration (FDA) approved the new drug application for its in-house discovered and developed orexin receptor antagonist Dayvigo (lemborexant). Dayvigo… Read More »

FDA Approves Enhertu (fam-trastuzumab deruxtecan-nxki) for HER2-Positive Unresectable or Metastatic Breast Cancer Following Two or More Prior Anti-HER2 Based Regimens

FDA Approves Enhertu (fam-trastuzumab deruxtecan-nxki) for HER2-Positive Unresectable or Metastatic Breast Cancer Following Two or More Prior Anti-HER2 Based Regimens Print this page 20 December 2019 — AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) today announced that the US Food and Drug Administration (FDA) has approved Enhertu® (fam-trastuzumab deruxtecan-nxki) for the treatment of adult… Read More »

FDA Approves Talicia To Treat Superbug Linked To Stomach Cancer

Health officials are increasingly concerned about the rise of antibiotic-resistant infections, also known as ‘superbugs’. However, this month an Israel-based pharmaceutical company showed that we may be able to combat this threat. The FDA approved Talicia to treat the increasing drug resistance Helicobacter pylori, news which suggests that the superbug apocalypse may not be as… Read More »