The BLA was resubmitted in 2025, after Atara and the FDA aligned on the criteria and addressed the initial CRL conditions.
The dual inhibition of PD-1 and VEGF pathways by ivonescimab aims to enhance immune response and limit tumor angiogenesis, ...
Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today announced that it has submitted a Biologics ...
Atara Biotherapeutics received a second complete response letter from the FDA for its biologics license application for ...
Atara Biotherapeutics stock drops on FDA rejection of EBVALLO BLA for serious post-transplant complication. FDA raises new ...
In July 2025, a class 2 resubmission of tab-cel’s BLA was initiated by Atara Biotherapeutics, developer and sponsor of ...
Tabelecleucel, an allogeneic, EBV-specific T-cell immunotherapy, works by targeting and eliminating EBV-infected cells.
The FDA has issued a second complete response letter to Atara Biotherapeutics for its biologicals license application of ...
AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to ...
On January 9, 2026, Pierre Fabre Pharmaceuticals, Inc. received a Complete Response Letter (CRL) from the U.S. Food and Drug ...
FDA assigned PDUFA target action date of July 7, 2026.If approved, atacicept would be the first B cell modulator targeting ...
MoonLake regains momentum after the FDA Type B meeting allows BLA submission for sonelokimab in HS without additional trials.
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