ImmunityBio's ANKTIVA sBLA for papillary bladder cancer was rejected by the FDA despite prior support, prompting the company to request urgent talks.

Qualification program creates a pathway to evaluate Clinical Outcome Assessments (COAs) that capture a specific concept of interest (COI) in a specified Context of Use (COU). If successfully qualified ...

Since returning to office for a second term, President Trump has taken steps to reshape federal agencies. Here, we discuss the significant ...

The idea of a purge followed by a blender is new, but the idea of a ‘supercenter’ isn’t. Back in 1982, FDA’s Bureau of Drugs ...

In a recent interview, FDA Commissioner Marty Makary said there “should be nothing political about the FDA.” Recent actions ...

He covers federal public health agencies. The Food and Drug Administration is drawing up plans that would end most of its routine food safety inspections work, multiple federal health officials ...

A major clinical win positions Penpulimab-kcqx as a new standard in advanced cancer care. HONG KONG, April 25, 2025 ...

HONG KONG, April 24, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is excited to announce that the U.S. Food and Drug Administration (FDA) has approved its differentiated PD-1 ...

The FDA’s drug center is asking its staff for volunteers to help out with contract and acquisition requests after the health ...

Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for ...

The tradipitant saga stretches back to September 2024, when the FDA declined to approve Vanda’s drug in gastroparesis, a ...