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 ...

The FDA is set to give its decision on SNY and REGN's sBLA for Dupixent for chronic spontaneous urticaria on April 18, 2025.

HCW Biologics shares skyrocketed as the company entered a licensing agreement with China's WY Biotech for an immunotherapeutic product candidate.

The deal is focused on a preclinical molecule that could potentially be used to treat age-related illnesses, such as cancer.

Aclaris Therapeutics (ACRS) shares surge 13% after exclusive global license deal for potential best-in-class biologics assets to bolster its pipeline.

U.S.-based HCW Biologics' (NASDAQ:HCWB) shares rallied in Monday's premarket trade, driven by a license, research and ...

The Committee discusses and makes recommendations for AstraZeneca (AZN) supplemental Biologics License Application (sBLA) 125586/546 for ...

The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental Biologics License ...

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.