The FDA approved Kisunla (donanemab-azbt, 350 mg/20 mL once-monthly injection for IV infusion), Eli Lilly and Company’s Alzheimer’s treatment for adults with early symptomatic Alzheimer’s disease (AD), which… read more.
Johnson & Johnson announced that the FDA has issued traditional approval for Sirturo (bedaquiline) as part of combination therapy in adult and pediatric patients (5 years and older… read more.
The FDA has granted full approval to selpercatinib (Retevmo) from Eli Lilly for the treatment of adult and pediatric patients at least 2 years of age with advanced… read more.
AbbVie announced the FDA has approved Skyrizi (risankizumab-rzaa) for adults with moderately to severely active ulcerative colitis, making it the first IL-23 specific inhibitor approved for both moderate… read more.
Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the extension of the Vabysmo (faricimab) marketing… read more.
GSK plc announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Omjjara (momelotinib) for the treatment of myelofibrosis. Omjjara is a once-a-day, oral JAK1/JAK2 and… read more.
Harmony Biosciences announced that the FDA has approved its supplemental New Drug Application (sNDA) for Wakix (pitolisant) tablets for the treatment of excessive daytime sleepiness (EDS) in pediatric… read more.
Novo Nordisk’s weight-loss drug Wegovy has been approved for sale in China, opening the door to a huge market in which obesity rates have more than doubled among… read more.
Johnson & Johnson MedTech unveiled Polyphonic, the open and secure digital ecosystem for a more connected surgical experience. The ecosystem features software applications that are agnostic to data… read more.
UCB, announced the first presentation of two-year data from the Phase III studies, BE MOBILE 1 and BE MOBILE 2, and the open-label extension, BE MOVING, evaluating bimekizumab,… read more.
AstraZeneca’s Farxiga (dapagliflozin) has been approved by the FDA to improve glycaemic control in paediatric patients with type-2 diabetes (T2D) aged 10 years and older. The FDA approval… read more.
Eisai Co. Ltd. and Biogen Inc. announced that that the FDA has accepted Eisai’s Supplemental Biologics License Application (sBLA) for monthly lecanemab-irmb (U.S. brand name: Leqembi) intravenous (IV)… read more.
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