Merck and Daiichi Sankyo have voluntarily withdrawn the U.S. Biologics License Application for ifinatamab deruxtecan in certain patients with previously treated extensive-stage small cell lung cancer after discussions with the FDA indicated that the submitted data did not meet the requirements for accelerated approval.
The FDA has granted Priority Review to Roche’s Enspryng (satralizumab) for MOGAD, a rare autoimmune CNS disease with no approved treatments, after Phase III METEOROID data showed a 68% relapse risk reduction.
Pfizer and Merck announce that the FDA has accepted a supplemental Biologics License Application (sBLA) for PADCEV in combination with KEYTRUDA for Priority Review in patients with muscle-invasive bladder cancer (MIBC).
Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the FDA for STELARA® (ustekinumab) to treat children aged two years and older with moderately to severely active ulcerative colitis. The filing is supported by data from the Phase 3 UNIFI Jr clinical trial, aiming to address the significant unmet needs for this pediatric patient population.
AbbVie reaches a key milestone by submitting a Biologics License Application (BLA) to the FDA for Pivekimab sunirine (PVEK), an investigational Antibody-Drug Conjugate (ADC) designed to treat the rare and aggressive blood cancer, Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN).
AstraZeneca‘s supplemental biologics license application (sBLA) for Imfinzi (durvalumab) has been approved and given priority review in the U.S. FDA for the treatment of patients with [Read More…]
Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the approval of STELARA® (ustekinumab) [Read More…]
AbbVie declared that they had submitted the Biologics License Application (BLA) for trenibotulinumtoxinE (TrenibotE) to the United States FDA for the treatment of moderate to severe glabellar lines. [Read More…]
In a randomized phase III study, Gazyva®/Gazyvaro® is the only anti-CD20 monoclonal antibody that shows a full renal response benefit.
