Sandoz announces the launch of Tyruko (natalizumab) in Germany from February Developed by Polpharma Biologics, Tyruko is the first and only biosimilar to treat RRMS.(r/r Multiple Sclerosis). Tyruko… read more.
Kite, a Gilead Company announced that the FDA has approved a manufacturing process change resulting in a shorter manufacturing time for Yescarta (axicabtagene ciloleucel). With this approval, Kite’s… read more.
Boston Scientific Corporation announced it has received FDA approval for the Farapulse Pulsed Field Ablation (PFA) System. The Farapulse PFA System is indicated for the isolation of pulmonary… read more.
Abbott announced that it received approval from the FDA to launch the Liberta RC DBS system, the world’s smallest rechargeable deep brain stimulation (DBS) device with remote programming,… read more.
Novocure announced that its Premarket Approval (PMA) application seeking approval for the use of Tumor Treating Fields (TTFields) therapy together with standard systemic therapies for the treatment of… read more.
Abbott and Tandem Diabetes Care, Inc. a leading insulin delivery and diabetes technology company, announced that the t:slim X2 insulin pump with Control-IQ technology is the first automated… read more.
Esperion announced that the FDA has approved an updated LDL-cholesterol lowering indication for Nexletol and Nexlizet to include the treatment of primary hyperlipidemia as a qualifier for existing… read more.
Octapharma USA announced the expansion of the FDA approval for wilate, von Willebrand Factor/Coagulation Factor VIII Complex (Human) Lyophilized Powder for Solution for Intravenous Injection. The approved label… read more.
Kite, a Gilead Company announced data from follow-up analyses of three studies of Yescarta (axicabtagene ciloleucel) that demonstrate the long-term survival potential for patients living with several sub-types… read more.
Theratechnologies Inc. announced that the FDA has approved the company’s Labelling Prior Approval Supplement to include a 2000-mg intravenous (IV) push loading dose for Trogarzo (ibalizumab-uiyk). IV push… read more.
Merck Inc., known as MSD outside of the United States and Canada, announced that the FDA has issued a Complete Response Letter (CRL) regarding Merck’s New Drug Application… read more.
Atara Biotherapeutics, Inc. announced the closing of the expanded global partnership with Pierre Fabre Laboratories for tabelecleucel (tab-cel or Ebvallo). Building on the earlier partnership announced in October… read more.
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