Tag Archives: Approves

FDA Approves Keytruda (pembrolizumab) for Patients With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer

Print this page KENILWORTH, N.J.–(BUSINESS WIRE) January 8, 2020 –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 Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with… Read More »

FDA Approves Ayvakit (avapritinib) for the Treatment of Adults with Unresectable or Metastatic PDGFRA Exon 18 Mutant Gastrointestinal Stromal Tumor

FDA Approves Ayvakit (avapritinib) for the Treatment of Adults with Unresectable or Metastatic PDGFRA Exon 18 Mutant Gastrointestinal Stromal Tumor Print this page CAMBRIDGE, Mass., Jan. 9, 2020 /PRNewswire/ — Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced that the U.S. Food… 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 Nouress (cysteine hydrochloride) Injection for Treating Neonate Patients Requiring Total Parenteral Nutrition (TPN)

FDA Approves Nouress (cysteine hydrochloride) Injection for Treating Neonate Patients Requiring Total Parenteral Nutrition (TPN) Print this page DUBLIN, Ireland, Dec. 16, 2019 (GLOBE NEWSWIRE) — Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced today that the U.S. Food and Drug Administration (FDA) has approved Nouress (AV001), a cysteine hydrochloride injection, a critical drug for treating neonatal… Read More »

FDA Approves Nouress (cysteine hydrochloride) Injection for Treating Neonate Patients Requiring Total Parental Nutrition (TPN)

FDA Approves Nouress (cysteine hydrochloride) Injection for Treating Neonate Patients Requiring Total Parental Nutrition (TPN) Print this page DUBLIN, Ireland, Dec. 16, 2019 (GLOBE NEWSWIRE) — Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced today that the U.S. Food and Drug Administration (FDA) has approved Nouress (AV001), a cysteine hydrochloride injection, a critical drug for treating neonatal… Read More »