Tag Archives: Approves

FDA Approves Wegovy (semaglutide) to Treat Adults with Obesity

FDA Approves Wegovy (semaglutide) to Treat Adults with Obesity PLAINSBORO, N.J., June 4, 2021 /PRNewswire/ — Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the new drug application (NDA) for Wegovy™ (semaglutide) injection 2.4 mg, the first-and-only prescription weight-loss medication with once-weekly dosing. Wegovy™ is used with a reduced calorie meal plan and… Read More »

FDA Approves Lybalvi (olanzapine and samidorphan) for the Treatment of Schizophrenia and Bipolar I Disorder

FDA Approves Lybalvi (olanzapine and samidorphan) for the Treatment of Schizophrenia and Bipolar I Disorder DUBLIN, June 1, 2021 /PRNewswire/ — Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved Lybalvi (olanzapine and samidorphan) for the treatment of adults with schizophrenia and for the treatment of adults with… Read More »

FDA Approves Pylarify (piflufolastat F 18) PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer

FDA Approves Pylarify (piflufolastat F 18) PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer May 27, 2021 — FDA has approved Pylarify (piflufolastat F 18) – a drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. With the approval of Pylarify, certain men with prostate… Read More »

FDA Approves Lumakras (sotorasib) for KRAS G12C-Mutated Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

FDA Approves Lumakras (sotorasib) for KRAS G12C-Mutated Locally Advanced Or Metastatic Non-Small Cell Lung Cancer THOUSAND OAKS, Calif., May 28, 2021 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Lumakras (sotorasib) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell… Read More »

FDA Approves Empaveli (pegcetacoplan) for Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH)

FDA Approves Empaveli (pegcetacoplan) for Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH) WALTHAM, Mass., May 14, 2021 (GLOBE NEWSWIRE) — Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved Empaveli™ (pegcetacoplan), the first and only targeted C3 therapy… Read More »

FDA Approves Zynrelef (bupivacaine and meloxicam) for the Management of Postoperative Pain

FDA Approves Zynrelef (bupivacaine and meloxicam) for the Management of Postoperative Pain SAN DIEGO, May 13, 2021 /PRNewswire/ — Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the U.S. Food… Read More »