J&J announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended expanding the Marketing Authorisation for Tremfya (guselkumab) to… read more.
Roche announced that the Phase III MUSETTE trial comparing a high dose of Ocrevus (ocrelizumab) intravenous (IV) infusion to the currently approved Ocrevus IV 600 mg dose in… read more.
Teva Pharmaceutical Industries Ltd. , and Samsung Bioepis Co., Ltd. announced the availability of Epysqli (eculizumab-aagh) in the U.S. Epysqli is a biosimilar to Soliris (eculizumab) for the… read more.
Recordati announced that the FDA has approved the supplemental new drug application (sNDA) for Isturisa (osilodrostat), for the treatment of endogenous hypercortisolemia in adults with Cushing’s syndrome for… read more.
Genmab announced that the European Commission (EC) has granted marketing authorization for Tivdak (tisotumab vedotin), an antibody-drug conjugate (ADC), as monotherapy treatment for adult patients with recurrent or… read more.
Boston Scientific announced positive 12-month primary endpoint results from the second phase of the ADVANTAGE AF clinical trial evaluating the use of the Farapulse Pulsed Field Ablation (PFA)… read more.
AstraZeneca’s Imfinzi (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as adjuvant monotherapy after radical cystectomy (surgery to remove the bladder) has been approved… read more.
Medtronic plc announced it has submitted 510(k) applications to the FDA seeking clearance for an interoperable pump. FDA clearance of this pump would pave the way for system integration… read more.
Pfizer announced that the FDA accepted for review a Biologics License Application (BLA) for MenABCWY, its investigational pentavalent meningococcal vaccine candidate. Pfizer submitted MenABCWY for the prevention of… read more.
GSK plc announced that the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has voted to recommend use of Penmenvy (Meningococcal Groups… read more.
Mirum Pharmaceuticals, Inc. announced that the FDA has approved Ctexli (chenodiol) tablets, a bile acid, for the treatment of adults with cerebrotendinous xanthomatosis (CTX). Ctexli is the first… read more.
BioMarin Pharmaceutical Inc. announced that the Phase III PEGASUS trial evaluating Palynziq (pegvaliase-pqpz) met its primary efficacy endpoint, demonstrating a statistically significant lowering in blood Phe levels in adolescents… read more.
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