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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.
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 ...
-Company Plans to Complete Rolling BLA Submission by End of 2024; Application May be Eligible for Priority Review by FDA-SAN DIEGO, Oct. 09, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, announced today that it has initiated its rolling submission process ...
April 11, 2022 FDA announced acceptance of Spectrum's re-submission of its Rolontis Biologics License Application (BLA)to FDA. Aug 6, 2021 Spectrum received a Complete Response Letter (CRL) from FDA for Rolontis (eflapegrastim). FDA cited to manufacturing deficiencies that required the manufacturing facilities to be re-inspected by FDA.
It was granted orphan drug designation by the US FDA for prevention of rabies virus infection including post-exposure prophylaxis (PEP) for rabies. The pivotal registration Phase 3 Trial was a randomized, comparator-controlled, double-blind, multicenter trial which includes 4,500 participants from the Philippines and Pakistan.
FDA Accepts Biogen Idec's Biologics License Application for First Long-Lasting Factor VIII Therapy for Hemophilia A -ELOCTATE ™ Has Potential to Provide Long-Lasting Protection and Markedly ...
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.
IND status requires the drug's sponsor to submit an IND application that includes data from laboratory and animal testing for safety and efficacy. [1] A drug that is made from a living organism or its products undergoes the same approval process but is called a biologics license application (BLA).