Alnylam Secures Positive CHMP Recommendation for Vutrisiran in Treating ATTR Amyloidosis with Cardiomyopathy In a significant regulatory milestone for RNA interference (RNAi) therapeutics, Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the industry leader in RNAi-based drug development, has announced that the Committee…
Pfizer’s Sasanlimab Boosts Event-Free Survival in High-Risk NMIBC Pfizer Inc. (NYSE: PFE) announced today significant findings from its pivotal Phase 3 CREST trial evaluating sasanlimab, an investigational anti-PD-1 monoclonal antibody, in combination with the standard of care (SOC) Bacillus Calmette-Guérin…
Coya Therapeutics Reports Positive Interim Results of IL-2 and CTLA4-Ig Combination in Mild to Moderate Frontotemporal Dementia Coya Therapeutics, Inc. , a clinical-stage biotechnology company specializing in the development of biologic therapies designed to enhance the function of regulatory T…
FDA Approves Second Manufacturing Facility for ADSTILADRIN (nadofaragene firadenovec-vncg) In a significant development for the biopharmaceutical industry, Ferring Pharmaceuticals has received approval from the U.S. Food and Drug Administration (FDA) for a state-of-the-art manufacturing hub dedicated to the production of…
Novocure’s Optune Lua® Earns CE Mark Approval for Treating Metastatic Non-Small Cell Lung Cancer In a significant development for the treatment of advanced lung cancer, Novocure announced that its innovative device, Optune Lua®, has received the Conformité Européenne (CE) Mark,…
Verastem Gets U.S. IND Clearance for KRAS G12D Inhibitor VS-7375, Paving Way for Phase 1/2a Trial in Solid Tumors Verastem Oncology (Nasdaq: VSTM), a Boston-based biopharmaceutical company at the forefront of developing precision oncology therapies, has announced a significant milestone…
FDA Grants Breakthrough Status to BrainChild Bio’s CAR T Therapy for Pediatric Brain Tumors BrainChild Bio, Inc., a clinical-stage biotechnology company at the forefront of neuro-oncology cell therapy innovation, has achieved a significant regulatory milestone with the announcement that its…
FDA Approves Dupixent as First New Targeted CSU Therapy in Over a Decade Chronic spontaneous urticaria, sometimes referred to as chronic idiopathic urticaria, is a condition characterized by the spontaneous appearance of hives (wheals), swelling (angioedema), or both, for six…
UK MHRA Approves Blenrep Combos for Relapsed/Refractory Multiple Myeloma GSK plc has achieved a critical regulatory milestone with the Medicines and Healthcare products Regulatory Agency (MHRA) granting authorisation for expanded use of Blenrep (belantamab mafodotin-blmf) in the United Kingdom. This…
Aptar Launches Study to Speed FDA Approval of SmartTrack™ Platform for Inhalers AptarGroup, Inc., a global leader in drug delivery and consumer product dispensing systems, has announced a pivotal step in the advancement of its pharmaceutical services with the initiation…
ACIP Backs Pfizer’s RSV Vaccine ABRYSVO for At-Risk Adults Aged 50–59 Pfizer Inc. (NYSE: PFE) has taken a significant step forward in the effort to combat respiratory syncytial virus (RSV) infections among U.S. adults, as the U.S. Centers for Disease…
GSK’s 5-in-1 Meningitis Vaccine PENMENVY Backed by U.S. Advisory Panel In a pivotal step forward for meningococcal disease prevention in the United States, GSK plc announced that the Advisory Committee on Immunization Practices (ACIP), an influential panel advising the US…