SOUTH SAN FRANCISCO, Calif., Oct. 13, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (DNLI) today announced that the U.S. Food and Drug Administration (FDA) has extended its review timeline of the ...
The dual inhibition of PD-1 and VEGF pathways by ivonescimab aims to enhance immune response and limit tumor angiogenesis, ...
Atara Biotherapeutics (NASDAQ: ATRA) has developed Ebvallo (tabelecleucel), a novel second-line immunotherapy for Epstein–Barr virus–positive post-transplant lymphoproliferative disease (EBV-PTLD).
MoonLake regains momentum after the FDA Type B meeting allows BLA submission for sonelokimab in HS without additional trials.
Larimar Therapeutics, Inc. has announced a refined timeline for submitting a Biologics License Application (BLA) for its treatment nomlabofusp, aimed at addressing Friedreich's Ataxia (FA). Based on ...
In July 2025, a class 2 resubmission of tab-cel’s BLA was initiated by Atara Biotherapeutics, developer and sponsor of ...
(RTTNews) - Denali Therapeutics (DNLI) announced that the FDA has accepted for review the Biologics License Application seeking accelerated approval for tividenofusp alfa for the treatment of Hunter ...
The FDA rejected a supplemental Biologics License Application (sBLA) for glofitamab-gxbm (Columvi, Genentech) in combination with gemcitabine and oxaliplatin for the second-line treatment of relapsed ...
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