Matthew Herper joins Adam and Allison to examine Prasad’s appointment and the band of outsiders now in charge of U.S. health ...

The US Food and Drug Administration will require all new vaccines to undergo placebo-controlled trials before approval — a ...

CBER’s new chief has argued for more stringent measures of assessing drugs for cancer and rare diseases, suggesting he might ...

The US Food and Drug Administration has named Dr. Vinay Prasad, a hematologist oncologist, to lead its Center for Biologics ...

By embracing a mix of co-innovation and best practices, stakeholders can boost productivity, streamline clinical trials, and ...

A version of meloxicam designed to work faster has beat out a placebo in two late-stage studies focused on post-surgical ...

BlackfinBio Limited has received approval from the FDA to trial a novel therapy for Hereditary Spastic Paraplegia ...

With the clinical hold on the tab-cel application lifted, phase 2 and 3 trials of the T-cell immunotherapy in patients with ...

ADRX-0706, a Nectin-4-targeted antibody-drug conjugate, has earned FDA fast track designation in advanced cervical cancer.

The FDA will decide whether to approve a once-daily, 25 mg oral formulation of semaglutide (Wegovy) by the end of 2025. If ...

The U.S. Food and Drug Administration (FDA) recently announced it plans to phase out animal testing in the development of monoclonal ...

FDA Commissioner Marty Makary’s proposal to roll out a new drug approval pathway is heightening hope for the rare disease ...