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…
Aetna Accelerates National Strategy to Simplify Healthcare for Providers and Patients Through Innovation, AI, and Integrated Care Models Aetna®, a CVS Health® company today announced significant progress on its ambitious, system-wide initiative to eliminate friction across the U.S. healthcare ecosystem—a…
FDA Grants Priority Review to AstraZeneca’s Baxdrostat for Hard-to-Control Hypertension—A Potential First-in-Class Therapy In a significant milestone for cardiovascular innovation, the U.S. Food and Drug Administration (FDA) has accepted AstraZeneca’s New Drug Application (NDA) for baxdrostat under Priority Review, signaling…
Johnson & Johnson Secures European Commission Approval for IMAAVY® (nipocalimab)—A Groundbreaking FcRn Blocker for Generalised Myasthenia Gravis In a landmark development for the treatment of generalized myasthenia gravis (gMG), Johnson & Johnson IMAAVY has announced that the European Commission (EC)…
Latus Bio Achieves Major Regulatory Milestone with IND Clearance and Triple FDA Designations for LTS-101 in CLN2 Disease Latus Bio, Inc., a clinical-stage biotechnology company at the forefront of adeno-associated virus (AAV) gene therapy innovation, has announced a significant advancement…
