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)…
BioNTech and Bristol Myers Squibb Unveil Promising Phase 2 Global Data for Pumitamig—First PD-L1xVEGF-A Bispecific Antibody—Demonstrating Encouraging Efficacy in Advanced Triple-Negative Breast Cancer BioNTech SE and Bristol Myers Squibb Company today announced the first interim data from a global randomized Phase 2 trial…
Bristol Myers Squibb reinforces its hematology leadership through new research across multiple therapies for patients with lymphoma at the 67th American Society of Hematology (ASH) Annual Meeting. Highlights include updates from the company’s targeted protein degradation pipeline, including data on…
Biogen and Stoke Present New Data Supporting Zorevunersen’s Disease-Modifying Potential in Dravet Syndrome at AES 2025 Biogen and Stoke Therapeutics, a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine, today announced data presentations that…
IDE034, a Bispecific Antibody-Drug Conjugate Licensed by Biocytogen to IDEAYA, Secures FDA IND Clearance Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), announced that its partner IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision oncology company, has received the clearance of…
