Novo Nordisk’s Wegovy® Becomes First Oral GLP-1 Therapy Approved in the U.S. for Weight Management Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the Wegovy® pill (once-daily oral semaglutide 25 mg) to reduce excess body…
EC approves TREMFYA® for pediatric plaque psoriasis — first IL-23 inhibitor for children Johnson & Johnson today announced that the European Commission (EC) has extended the marketing authorisation for TREMFYA® (guselkumab) as a subcutaneous treatment to treat moderate to severe Pediatric plaque…
Johnson & Johnson Supports HRS Registry to Enhance Real-World Evidence for PFA ohnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, today announced its sponsorship of a new data collection platform developed by the Heart Rhythm Society (HRS) to…
Johnson & Johnson Secures FDA Approval for TRUFILL n-BCA Liquid Embolic System to Treat Symptomatic Chronic Subdural Hematoma Johnson & Johnson MedTech, a leader in neurovascular care, announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication…
Novo Nordisk Submits FDA Application for CagriSema—First Once-Weekly Combination of GLP-1 and Amylin Analogues for Weight Management Today, Novo Nordisk announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for once-weekly CagriSema…
WHO Hosts Second Global Summit to Advance Evidence, Integration, and Innovation in Traditional Medicine The World Health Organization (WHO)’s Second Global Summit on Traditional Medicine, jointly organized with the Government of India, opens today, bringing together government ministers, scientists, Indigenous leaders,…
KEYTRUDA® Combined with Padcev® Significantly Boosts Event-Free Survival, Overall Survival, and Pathologic Complete Response Rates in Cisplatin-Eligible Patients with Muscle-Invasive Bladder Cancer When Administered Perioperatively Merck, known as MSD outside the United States and Canada, today announced positive topline results…
Novo Nordisk A/S: EMA Recommends Higher-Dose Wegovy® for Obesity, Delivering Average Weight Loss of 20.7% Today, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for a higher dose of Wegovy® (semaglutide 7.2…
Blujepa (gepotidacin) Receives US FDA Approval as Oral Treatment for Uncomplicated Urogenital Gonorrhea (uGC) GSK plc today announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application for gepotidacin as an oral option for…
FDA Grants Priority Review to Bristol Myers Squibb’s Opdivo® (nivolumab) Plus Chemotherapy for Classical Hodgkin Lymphoma Bristol Myers Squibb today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to the supplemental Biologics License…
FDA Approves UPLIZNA® for Use in Adults with Generalized Myasthenia Gravis Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved UPLIZNA® (inebilizumab-cdon) for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle…
Teva Pharmaceuticals Files New Drug Application with FDA for Once-Monthly Olanzapine Extended-Release Injectable Suspension (TEV-‘749) to Treat Schizophrenia in Adults Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., today announced the submission of a New Drug Application (NDA)…