EMA gives positive opinion to Fexinidazole Winthrop as first oral treatment of acute form of sleeping sickness found in East and Southern Africa
Sanofi, DNDi and the HAT-r-ACC consortium announce the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive scientific opinion of Fexinidazole Winthrop as…
AMGEN ANNOUNCES EXECUTIVE APPOINTMENTS TO ACCELERATE INNOVATION
Amgen (NASDAQ:AMGN) today announced two changes to its senior leadership team in the areas of research and development (R&D) and technology, underscoring the advancement of the company’s robust pipeline and its…
AMGEN TO SPONSOR THE IRISH OPEN
Amgen (NASDAQ:AMGN) today announced it will serve as the title sponsor of the Irish Open starting in 2024, following the acquisition of Horizon Therapeutics plc in October 2023. Horizon Therapeutics, a leading…
FDA GRANTS PRIORITY REVIEW TO AMGEN’S TARLATAMAB APPLICATION FOR ADVANCED SMALL CELL LUNG CANCER
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Company’s Biologics License Application (BLA) for tarlatamab. Tarlatamab is a potential first-in-class, investigational…
Vertex Receives CHMP Positive Opinion for the First CRISPR/Cas9 Gene-Edited Therapy, CASGEVY™ (exagamglogene autotemcel), for the Treatment of Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the conditional approval of…
Vertex Announces Positive Results From Phase 2 Study of VX-548 for the Treatment of Painful Diabetic Peripheral Neuropathy
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced positive results from its Phase 2 dose-ranging study of the selective NaV1.8 inhibitor VX-548 in people with painful diabetic peripheral neuropathy (DPN). Treatment with…
Positive CHMP Opinion by EMA for Arpraziquantel to Treat Schistosomiasis in Preschool-Aged Children
Merck, a leading science and technology company, and the Pediatric Praziquantel Consortium today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a…
Chugai Files for Additional Indication of Alecensa for Postoperative Adjuvant Therapy for ALK Fusion Gene-Positive Non-Small Cell Lung Cancer
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) today announced that it filed regulatory application with the Ministry of Health, Labour and Welfare (MHLW) for the additional indication of an ALK inhibitor Alecensa® Capsules…
Takeda Receives Positive CHMP Opinion for HYQVIA® as Maintenance Therapy in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Takeda (TSE:4502/NYSE:TAK) today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]…
CHMP Issues Positive Opinion for Biogen’s SKYCLARYS®, the First Therapy to Treat Friedreich’s Ataxia, a Rare Neurodegenerative Disease
Biogen Inc. (Nasdaq: BIIB) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing authorization for SKYCLARYS® (omaveloxolone) for the treatment of Friedreich’s ataxia…
ZURZUVAE™ (zuranolone) CIV, a Landmark Oral Treatment for Women with Postpartum Depression (PPD), is Now Available in the U.S.
Biogen Inc. (Nasdaq: BIIB) and Sage Therapeutics, Inc. (Nasdaq: SAGE) announced ZURZUVAE™ (zuranolone) 50 mg (two 25 mg capsules per day) CIV is now available by prescription for the treatment of postpartum…
PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) Approved by FDA as the First and Only ADC Plus PD-1 to Treat Advanced Bladder Cancer
Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”)today announced that on December 15, 2023 the U.S. Food and Drug Administration (FDA) has approved…