Autolus Therapeutics plc an early-commercial stage biopharmaceutical company developing next-generation programmed T cell therapies, announces the FDA has granted marketing approval for Aucatzyl (obecabtagene autoleucel) for the… read more.
Boston Scientific Corporation announced positive three-year primary endpoint results from the OPTION global clinical trial of the Watchman FLX Left Atrial Appendage Closure (LAAC) Device. Key findings from… read more.
Royal Philips, a global leader in health technology, announced its next-generation 1.5T BlueSeal MR wide-bore scanner will be unveiled at RSNA 2024. The latest generation scanner features a… read more.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on the results from the LAURA Phase III trial,… read more.
Azurity Pharmaceuticals announced that the FDA has approved Danziten, the first and only nilotinib with no mealtime restrictions indicated for adult patients with newly diagnosed Philadelphia chromosome positive… read more.
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.
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