PTC Therapeutics, Inc. announced the FDA accelerated approval of its gene therapy for the treatment of AADC deficiency, the first-ever gene therapy approved in the United States that… read more.
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the FDA has accepted for review the resubmission of the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) to treat adults… read more.
InflaRx N.V., a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)… read more.
Ipsen announced late-breaking data for Iqirvo (elafibranor 80 mg tablets) from an interim analysis of the ongoing open-label extension of the Phase III ELATIVE study at the American… read more.
Sandoz, announced that the European Commission (EC) has granted marketing authorization for Afqlir (aflibercept) 2 mg vial kit and pre-filled syringe for intravitreal injection, a biosimilar to reference… read more.
Shorla Oncology , a U.S.-Ireland specialty pharmaceutical company, announced that the FDA has expanded the approval of Jylamvo (methotrexate) to include the treatment of pediatric patients with acute… read more.
Eisai Co., Ltd and Biogen Inc. announced that the latest findings for lecanemab-irmb (U.S. brand name: Leqembi), an anti-amyloid beta (Aβ) protofibril antibody for the treatment of early… read more.
Positive high-level results of KOMET, the largest, global randomised double-blind placebo-controlled multicentre Phase III trial in adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas… read more.
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders announced 48-week findings from the DOLCE study, sponsored by Fundación Huésped… read more.
Avapritinib is recommended, within its marketing authorisation, as an option for treating advanced systemic mastocytosis (including aggressive systemic mastocytosis, systemic mastocytosis with an associated haematological neoplasm and mast… read more.
Johnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, announced the FDA approval of the Varipulse Platform for the treatment of drug refractory paroxysmal Atrial Fibrillation… read more.
Bayer announced 510(k) clearance from the FDA for its Medrad Centargo CT Injection System, an innovative multi-patient injector that drives workflow efficiency with design features that integrate with… read more.
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