Global pharmaceutical major Lupin Limited announced today that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Raltegravir Tablets USP, 600 mg. These tablets are the generic…
Teva and Alvotech Expand U.S. Biosimilar Portfolio with Approval for SELARSDI™ Teva Pharmaceuticals, the U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Alvotech (NASDAQ: ALVO) have announced that the U.S. Food and Drug Administration (FDA) has…
Genmab to Submit sBLA to FDA for Epcoritamab Combo in Relapsed/Refractory Follicular Lymphoma Genmab A/S, a leading international biotechnology company specializing in the development of antibody therapeutics for the treatment of cancer and other serious diseases, announced today its intention…
Xencor Reports Positive Early Data for Anti-TL1A Antibody in Bowel Disease Xencor, Inc. a leading clinical-stage biopharmaceutical company specializing in the development of engineered antibodies for the treatment of cancer and autoimmune diseases, has announced positive interim results from the…
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…