Vertex Announces FDA Acceptance of Suzetrigine NDA for Acute Pain Vertex Pharmaceuticals today revealed that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for suzetrigine, an investigational oral NaV1.8 pain signal inhibitor designed to…
Novartis announced that the US Food and Drug Administration (FDA) has granted Priority Review status to Scemblix® (asciminib) for the treatment of newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). The FDA’s Priority…
Global pharmaceutical leader Lupin Limited (Lupin) has announced the approval of its Abbreviated New Drug Application by the United States Food and Drug Administration (U.S. FDA) for Topiramate Extended-Release Capsules. This approval covers dosages of 25 mg, 50 mg, 100…
Today, AbbVie announced that it has submitted applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for a new indication for upadacitinib (RINVOQ®; 15 mg, once daily) to treat adult patients with giant cell…
Daiichi Sankyo (TSE: 4568) has inaugurated a new affiliate dedicated to its oncology business in Athens, Greece, underscoring its commitment to addressing the needs of cancer patients in Europe. Thomais Konstantopoulou has been appointed as the Country Manager for Daiichi…
The United States Food and Drug Administration (US FDA) has approved the Vabysmo® (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for treating neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion…
The Antibiotic Collaboration and Licensing Deals 2016-2024 report has been added to ResearchAndMarkets.com’s offerings. This report provides a comprehensive understanding and unprecedented access to antibiotic deals made by the world’s leading biopharma companies, covering agreements from 2016 to 2024. It…
During its annual event “BIG UP,” French Tech Saint-Etienne Lyon awarded the prestigious BIG Start-up of the Year trophy, recognizing a start-up that embodies innovation and vitality within the region. Established in 2015, French Tech Saint-Etienne Lyon is a non-profit…
Sanofi’s CD40L monoclonal antibody, frexalimab, has demonstrated promising results in reducing a key biomarker associated with nerve cell damage in patients with relapsing multiple sclerosis (MS), suggesting potential benefits in delaying disability progression. Phase 2 findings presented at the 10th…
argenx Receives FDA Approval for VYVGART® Hytrulo with ENHANZE® for Chronic Inflammatory Demyelinating Polyneuropathy Today, Halozyme announced that the U.S. Food and Drug Administration (FDA) has approved argenx’s VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) co-formulated with ENHANZE® for the treatment…
Today, Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for KRAZATI® (adagrasib) in combination with cetuximab. This targeted treatment is for adult patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC),…
FDA Approves SKYRIZI® for Ulcerative Colitis, Expanding AbbVie’s IBD Portfolio AbbVie announced that the U.S. FDA has approved SKYRIZI® (risankizumab-rzaa) for adults with moderately to severely active ulcerative colitis. This marks SKYRIZI as the first IL-23 specific inhibitor approved for…
