Pfizer has decided to terminate the development and commercialization of its hemophilia B gene therapy fidanacogene elaparvovec (marketed as Beqvez) globally, resulting in the withdrawal of its regulatory… read more.
NICE (UK): 1.1 Vadadustat is recommended, within its marketing authorisation, as an option for treating symptomatic anaemia caused by chronic kidney disease in adults having maintenance dialysis. Vadadustat… read more.
Gilead Sciences, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending seladelpar for the… read more.
GSK plc announced that the FDA has approved Penmenvy (Meningococcal Groups A, B, C, W, and Y Vaccine) for use in individuals aged 10 through 25 years. The… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Tivdak, ( tisotumab vedotin) intended for the… read more.
Eli Lilly and Company announced results from the VIVID-2 open-label extension study, which showed the majority of patients with moderately to severely active Crohn’s disease receiving two years… read more.
AstraZeneca’s Imfinzi (durvalumab) has been approved in the US for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following… read more.
The FDA has approved nivolumab and hyaluronidase-nvhy (Opdivo Qvantig, Bristol Myers Squibb Company) for subcutaneous injection across approved adult, solid tumor nivolumab (Opdivo, Bristol Myers Squibb Company) indications… read more.
Bayer announced the submission of a marketing authorization application to the Ministry of Health, Labour, and Welfare (MHLW) in Japan, seeking approval of finerenone in adult patients with… read more.
Johnson & Johnson announced the submission of two supplemental Biologics License Applications (sBLAs) to the FDA seeking approval of Tremfya (guselkumab) for the treatment of children 6 years… read more.
GSK plc announced that the China National Medical Products Administration has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as an add-on therapy with intranasal corticosteroids… read more.
AbbVie announced that the FDA has approved Emblaveo (aztreonam and avibactam), as the first and only fixed-dose, intravenous, monobactam/β-lactamase inhibitor combination antibiotic. It is approved in combination with… read more.
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