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.
Veoza (Veozah in the US), also known as fezolinetant, from Astellas, has been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) after receiving similar approval in… read more.
The FDA has approved eflornithine (Iwilfin, USWM, LLC) to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least… read more.
On 14 December 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product… read more.
Biogen Inc. announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing authorization for Skyclarys (omaveloxolone) for the treatment of… read more.
Arcutis Biotherapeutics, Inc. announced the FDA has approved the new drug application (NDA) for Zoryve (roflumilast) topical foam, 0.3% for the treatment of seborrheic dermatitis in individuals 9… read more.
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