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NMIBC BCG Unresponsive Papillary Disease: ImmunityBio is preparing to submit a supplemental Biologics License Application (sBLA) in 2025 for its treatment targeting Bacillus Calmette-Guérin (BCG ...
A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680.
COPENHAGEN, Denmark, Sept. 30, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food & Drug Administration (FDA) for TransCon hGH (marketed as SKYTROFA ® (lonapegsomatropin-tcgd) in the U.S. for pediatric growth hormone deficiency) for the treatment of adults with growth hormone ...
Iovance Biotherapeutics Inc (NASDAQ: IOVA) announced that its ongoing rolling Biologics License Application (BLA) submission to the FDA for lifileucel is expected to be completed in the first ...
Roche's (RHHBY) sBLA seeking approval for the use of Polivy in combination with R-CHP for previously untreated diffuse large B-cell lymphoma in adults has been accepted in the United States.
TARRYTOWN, N.Y., Aug. 20, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for linvoseltamab in relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies.
The FDA accepts Bristol Myers' (BMY) sBLA for Breyanzi under a priority review as a second-line treatment for relapsed/refractory large B-cell lymphoma. A decision is due on Jun 24, 2022.
The US Food and Drug Administration (FDA) granted the application for moxetumomab pasudotox fast track, priority review, and orphan drug designations. [4] [17] The FDA granted the approval of a Biologics License Application for Lumoxiti to AstraZeneca Pharmaceuticals. [4] This was subsequently transferred to Innate Pharma in March 2020. [18]