Pharmaceuticals announced that the Food and Drug Administration has extended the target action dates to Q4 of 2025 for two Eylea ...

WuXi has a wide range of technical platforms for state-of-the-art biologic innovations, including the bispecific and multispecific antibodies platform under WuXiBody, the Chinese hamster ovary ...

In this Healio Video Perspective from the Retina World Congress, Huma Qamar, MD, MPH, of Ocugen, overviews programs for ...

The firm plans to submit CMC data for DTX401 informed by the FDA's observations related to an application for its Sanfilippo syndrome type A gene therapy.

IO Biotech plans to meet with the FDA this fall to discuss the data from the phase 3 trial of Cylembio and determine next ...

The FDA issued a complete response letter to the odronextamab application in follicular lymphoma, rejecting the drug for a second time in this patient population. The FDA has issued a complete ...

On track to submit a Biologics License Application (BLA) for accelerated approval of atacicept to U.S. FDA in Q4 2025; potential commercial launch in 2026 Announced positive primary endpoint results ...

The company is advancing late-stage trials for rare retinal diseases while actively restructuring to support multiple Biologics License Application (BLA) submissions over the next three years.

Mesoblast has filed a Biologics License Application to the United States Food and Drug Administration (FDA) to seek approval of its product candidate RYONCIL™ (remestemcel-L) for steroid ...

Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for Breyanzi ® (lisocabtagene ...

The FDA accepted the biologics license application (BLA) for BAT2506, a proposed biosimilar to Simponi (golimumab). 1 This biosimilar, developed by Bio-Thera Solutions, aims to treat several ...