A former critic of FDA and Pharma will now oversee the regulation of costly and complicated biologics like vaccines, gene therapies, and blood supply.

Michael Rogers, a top official at the Food and Drug Administration, announced Monday he is retiring amid the Trump ...

The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve ...

changes in FDA leadership; and (3) plans to reorganize the Agency and reduce its workforce. On March 25, 2025, Martin "Marty" Makary was confirmed by the Senate to be the 27th Commissioner of Food ...

In his new role with the FDA, Dr. Vinay Prasad will oversee the regulation of costly drugs, including vaccines, gene ...

Now is the time for the biotechnology sector to ask for big changes to the FDA, NIH, reimbursement, intellectual property and ...

The FDA's decision to appoint Vinay Prasad, MD, MPH, to head its Center for Biologics Evaluation and Research (CBER) raised ...

Regulatory environment tightening with FDA leadership change, adding uncertainty to Sarepta's near-term outlook and potential delays in approvals. However, the stock has underperformed since then ...

Amid a slew of recent shake-ups at the FDA—including the agency’s reduction in force and high-profile leadership exits—the regulator is ushering in "radical" changes to how it signs off on ...

West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, today announced executive leadership changes as part of its succession ...

ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced that the Company received a Refusal to ...