Regenxbio is pushing its Duchenne muscular dystrophy gene therapy into pivotal development, with a BLA planned for ...
The US Food and Drug Administration (FDA) has accepted a resubmission of the supplemental Biologics License Application for ...
Zacks.com on MSN17h
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 ...
The Committee discusses and makes recommendations for AstraZeneca (AZN) supplemental Biologics License Application (sBLA) 125586/546 for ...
For patients with previously treated EGFR-mutated NSCLC, a new BLA has been submitted to the FDA seeking the accelerated ...
The resubmitted sBLA will include results from Study C, which evaluated biologic-naive patients with uncontrolled CSU on antihistamines.
The FDA has accepted for review the resubmitted BLA for prademagene zamikeracel for recessive dystrophic epidermolysis bullosa.
The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.
The FDA has provided a date of April 18, 2025, to review the application for Dupixent to treat patients with chronic ...
Adaptimmune’s Phase II IGNYTE-ESO trial investigating experimental T cell therapy lete-cel has achieved its primary endpoint.
Wong, Founder and CEO of HCW Biologics, stated, “In the third quarter 2024, the Company expanded our product portfolio and possible disease indications that may be treated with our immunotherapeutic ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback