Nature

Center for Biologics Evaluation and Research (CBER), USFDA

Note: Articles may be assigned to more than one subject area, as a result the sum of the subject research outputs may not equal the overall research outputs. Identify research insights to guide ...

UniQure shares surge 26% on US FDA shakeup even as momentum tumbles: Will new leadership greenlight Huntington's therapy?

uniQure N.V. QURE shares skyrocketed on Monday following news that Dr. Vinay Prasad, head of the FDA's Center for Biologics ...
PharmExec

Vinay Prasad Out at CBER for Second Time in Under a Year

The second exit in under a year follows controversy around CRLs for Replimune and Capricor, including criticism that mid- and ...
BioSpace

FDA’s Prasad To Depart FDA Following Tumultuous Term as CBER Chief

Center for Biologics Evaluation and Research Director Vinay Prasad will exit the FDA for the second time after a controversial run that saw the oncologist butt heads with colleagues and ruffle ...
Pharmabiz

Shilpa Biologicals and mAbTree Biologics secure US FDA orphan drug designation for breakthrough biologics to treat rare blood cancers

Shilpa Biologicals and mAbTree Biologics secure US FDA orphan drug designation for breakthrough biologics to treat rare blood cancers: Our Bureau, Bengaluru Friday, March 13, 2026 ...
Seeking Alpha

Dr. Reddy’s Announces USFDA Acceptance to Review Its Biologics License Application (BLA) for Proposed Interchangeable Biosimilar, Abatacept

Following the submission in December 2025, USFDA has accepted Dr. Reddy’s 351(k) Biologics License Application (BLA) for Proposed Interchangeable biosimilar Abatacept, DRL_AB (IV for Infusion) BLA is ...