The BLA was resubmitted in 2025, after Atara and the FDA aligned on the criteria and addressed the initial CRL conditions.
In July 2025, a class 2 resubmission of tab-cel’s BLA was initiated by Atara Biotherapeutics, developer and sponsor of ...
The dual inhibition of PD-1 and VEGF pathways by ivonescimab aims to enhance immune response and limit tumor angiogenesis, ...
A complete response letter is a formal communication from the FDA indicating that an application cannot be approved in its present form. In the case of Outlook Therapeutics, the FDA noted that while ...
Detailed price information for Sangamo Therapeutics (SGMO-Q) from The Globe and Mail including charting and trades.
MELVILLE, N.Y., Nov. 17, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX) , a ...
The U.S. Food and Drug Administration (FDA) is now releasing complete response letters (CRLs) for BLA and NDA products not yet approved – including CRLs associated with pending or withdrawn ...
WALTHAM, Mass., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (IVVD) today announced it has received and is aligned with advice from the U.S. Food and Drug Administration (FDA) on a compact and, ...
Zacks Investment Research on MSN
OTLK stock crashes 67% in a week: Here's what you need to know
Shares of Outlook Therapeutics OTLK have tumbled 66.5% in a week. The massive crash was observed after the FDA issued a third ...
US biotech Ultragenyx Pharmaceutical In this week revealed that it has completed the rolling submission of its Biologics ...
Investing.com -- uniQure N.V. (NASDAQ:QURE) stock rose 15% Friday morning after the gene therapy company announced a ...
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