The US Food and Drug Administration (FDA) has accepted a resubmission of the supplemental Biologics License Application for ...
Regenxbio is pushing its Duchenne muscular dystrophy gene therapy into pivotal development, with a BLA planned for ...
HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on ...
For patients with previously treated EGFR-mutated NSCLC, a new BLA has been submitted to the FDA seeking the accelerated ...
The Committee discusses and makes recommendations for AstraZeneca (AZN) supplemental Biologics License Application (sBLA) 125586/546 for ...
GlobalData on MSN3d
FDA reviews Sanofi and Regeneron’s Dupixent label expansion for urticariaThe FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.
Shares of Omeros touched a 52-week high, a day after the company said it could resubmit its biologics license application for narsoplimab to the Food and Drug Administration. In Thursday afternoon ...
Zacks.com on MSN19h
FDA Accepts SNY and REGN's Dupixent Re-Submitted sBLA for UrticariaSanofi SNY and partner Regeneron REGN announced that the FDA has accepted their resubmitted supplemental biologics license ...
After feedback from the FDA, the companies have voluntarily withdrawn the previous biologics licensing application for ...
Target patient enrollment of 92 evaluable patients achieved in the VIRAGE Phase 2b clinical trial of VCN-01 in patients with metastatic ...
GlobalData on MSN4d
Adaptimmune nears second sarcoma approval as Phase II trial hits endpointsAdaptimmune’s Phase II IGNYTE-ESO trial investigating experimental T cell therapy lete-cel has achieved its primary endpoint.
The FDA has accepted for review the resubmitted BLA for prademagene zamikeracel for recessive dystrophic epidermolysis bullosa.
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