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.
Amgen announced that the global Phase III DeLLphi-304 clinical trial evaluating Imdelltra (tarlatamab-dlle) as a treatment for patients with small cell lung cancer (SCLC) who progressed on or… read more.
Valneva SE announced that the Brazilian Health Regulatory Agency (ANVISA) approved Ixchiq vacccine for the prevention of disease caused by the chikungunya virus in individuals 18 years of… read more.
Johnson & Johnson MedTech announced 12-month results from the SmartfIRE study, presented as a late-breaking presentation at the annual meeting of the European Heart Rhythm Association (EHRA) in… read more.
The FDA approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those that are life-threatening (anaphylaxis), in adult and pediatric patients who… read more.
New results show Eli Lilly and Company’s Ebglyss achieved deep and sustained response for patients with moderate-to-severe atopic dermatitis (eczema) at three years. These findings from the ADjoin… read more.
Eisai Co., Ltd. and Biogen Inc. announced an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab as a treatment for early AD (mild… read more.
AbbVie announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of upadacitinib (Rinvoq 15 mg, once daily) for… read more.
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