Sanofi and Alnylam Secure Landmark RNAi Approval for Hemophilia A & B Sanofi and Alnylam have achieved a significant milestone with the U.S. Food and Drug Administration (FDA) granting approval to fitusiran, their RNA interference (RNAi) therapy, for the treatment…
European Commission Approves TIVDAK® for Recurrent or Metastatic Cervical Cancer Genmab A/S has announced that the European Commission (EC) has officially granted marketing authorization for TIVDAK® (tisotumab vedotin), an antibody-drug conjugate (ADC), as a monotherapy treatment for adult patients diagnosed…
Vertex Pharmaceuticals Secures UK MHRA Approval for ALYFTREK®, a Next-Generation CFTR Modulator for Cystic Fibrosis Vertex Pharmaceuticals announced today that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for ALYFTREK® (deutivacaftor/tezacaftor/vanzacaftor), a next-in-class, once-daily…
Japan Approves TIVDAK® for Advanced Cervical Cancer Treatment Genmab A/S has announced that the Japan Ministry of Health, Labour and Welfare (MHLW) has approved TIVDAK® (tisotumab vedotin) for the treatment of advanced or recurrent cervical cancer that has progressed following…
Health Canada Approves 4Moving Biotech’s Phase 2a Trial for Knee Osteoarthritis 4Moving Biotech (4MB), a spin-off of 4P-Pharma dedicated to developing first-in-class treatments that modify the natural history of knee osteoarthritis, has received authorization from Health Canada to initiate the…
FDA Approves CABOMETYX® (Cabozantinib) for Advanced Neuroendocrine Tumors, Expanding Treatment Options Exelixis, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved CABOMETYX® (cabozantinib) for the treatment of adult and pediatric patients aged 12 years and older…
Coya Therapeutics Advances Treg-Derived Exosome Program Coya Therapeutics, Inc. (“Coya” or the “Company”), a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell (Treg) function, has provided a comprehensive update on its investigational regulatory T cell-derived exosome…
FDA Approves Blujepa (Gepotidacin) for uUTIs in Adults & Teens GSK plc has announced that the US Food and Drug Administration (FDA) has approved Blujepa (gepotidacin) for the treatment of uncomplicated urinary tract infections (uUTIs) in female adults (weighing ≥40…
Novartis’ Fabhalta® (iptacopan) Wins Third FDA Approval for C3G Novartis has announced that the U.S. Food and Drug Administration (FDA) has approved oral Fabhalta® (iptacopan) for the treatment of adults with C3 glomerulopathy (C3G) to reduce proteinuria. This milestone makes…
Omeros Updates Phase 3 Zaltenibart PNH Trial Omeros Corporation has announced that site activation for enrollment is underway in its Phase 3 clinical trial program evaluating zaltenibart (OMS906) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). Zaltenibart is an investigational…
NeuroSense Therapeutics Advances Toward Early Canadian Commercialization of ALS Drug NeuroSense Therapeutics Ltd. has announced significant progress toward the early commercialization of PrimeC in Canada. According to a Form 6-K filed with the SEC this morning, Health Canada has invited…
InnoCare Doses First Patient in Phase III Trial of ICP-488 for Psoriasis in China InnoCare Pharma, a leading biopharmaceutical company dedicated to developing innovative treatments for cancer and autoimmune diseases, has announced a significant milestone in its clinical development efforts.…