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April 26, 2024
Beqvez (fidanacogene elaparvovec-dzkt), a one-time gene therapy, helps adults with hemophilia B produce factor IX themselves instead of receiving regular intravenous infusions.
April 24, 2024
GSK’s supplemental Biologics License Application for its PD-1-blocking antibody therapy has been accepted for review by FDA.
March 29, 2024
J&J’s nipocalimab is in development for reducing the risk of FNAIT in alloimmunized pregnant adults, a rare disease that may risk the life of the fetus or newborn.
March 28, 2024
AstraZeneca notes that Ultomiris is the first and only long-acting C5 complement inhibitor that offers NMOSD patients the potential to live without relapsing.
March 27, 2024
AbbVie’s acquisition of Landos includes a lead asset that boosts its portfolio in autoimmune and inflammatory diseases, while the ADC, ELAHERE, gets full FDA approval.
March 19, 2024
Orchard Therapeutics’ Lenmeldy (atidarsagene autotemcel) marks the first gene therapy approved in the US for treating children with metachromatic leukodystrophy.
March 08, 2024
EMA has validated two MAAs submitted by AstraZeneca and Daiichi Sankyo for datopotamab deruxtecan in two types of cancer.
February 27, 2024
The agency has recommended granting marketing authorization to ALS treatment, Qalsody (tofersen), for adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.
February 22, 2024
Daiichi Sankyo is investing approximately €1 billiion (US$1.08 billion) to expand its Pfaffenhofen an der Ilm, Germany, site for ADC development and production.
February 20, 2024
FDA has approved Iovance Biotherapeutics’ Amtagvi (lifileucel) for treating patients with unresectable or metastatic melanoma.