Shares of Omeros touched a 52-week high, a day after the company said it could resubmit its biologics license application for narsoplimab to the Food and Drug Administration. In Thursday afternoon ...
Reports Q3 revenue $0 vs. $0 last year. “With the acceptance of our Biologics License Application resubmission for pz-cel, we are ramping up our commercial readiness efforts, especially with respect ...
UK-based Adaptimmune will submit a rolling Biologics License Application (BLA) to the US Food and Drug Administration (FDA) ...
AstraZeneca and Daiichi Sankyo have submitted a new Biologics License Application (BLA) for accelerated approval in the US ...
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ANX005 in Guillain-Barré syndrome (GBS): First-in-kind monoclonal antibody designed to block C1q and the entire classical complement pathway in both the body and the brain has the potential to be the ...
FDA accepts BLA resubmission of pz-cel in recessive dystrophic epidermolysis bullosa and sets PDUFA target action date of ...
FDA accepts BLA resubmission of pz-cel in recessive dystrophic epidermolysis bullosa and sets PDUFA target action date of April 29, 2025 Company makes significant progress toward potential commerciali ...
As described in previous updates, we have been working closely with FDA regarding the anticipated resubmission of our Biologics License Application, or BLA for narsoplimab in hematopoietic stem cell ...
Following strong treatment response data for Adaptimmune’s lete-cel, the biotech is planning to initiate a rolling BLA ...
The CHMP recommends approval of lecanemab for the treatment of mild cognitive impairment (MCI) and mild dementia caused by Alzheimer's disease, in adult patients who are heterozygotes (carry one copy) ...
1. About lecanemab (generic name, brand name: Leqembi®) Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal ...
The approval marks the first time gene therapy will be available to treat patients with aromatic I-amino acid decarboxylase ...
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