In a long-sought move, the Food and Drug Administration on Thursday formally began the process of abandoning oral doses of a ...

The integration of AI into drug submission and approval processes signifies a shift towards more efficient pharmaceutical development. The potential benefits are substantial, including faster ...

there are 64 oncology drug indications on the US market with accelerated approvals only. The FDA estimates the accelerated ...

Developer Autolus set a list price of $525,000 for its new cell therapy, which it will sell for a type of leukemia under the ...

At the center of this fight is how the FDA regulates a possible "functional cure" for Type 1 diabetes and determines who gets ...

The new director at the FDA overseeing medical devices will confront criticisms about hasty approvals as she ushers in ...

Alzheimer’s disease robs patients of so much more than their health. It can rewire their personalities and undermine a ...

RFK Jr., a longtime anti-vaccine activist, to play a role in Trump administration and potentially influence how the FDA and ...

The Food and Drug Administration ... in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant," Dr. Patrizia Cavazzoni, director of the FDA's ...

FELIQS plans to conduct a Phase 1b/2 study of FLQ-101 (tROPhy-1 study) both in the US and Japan in the first quarter of 2025.

With Donald Trump now confirmed as the President-elect, the life sciences industry is bracing for significant policy shifts that could impact everything from drug pricing to regulatory practices. Trum ...

President-elect Trump’s promise to let Robert F. Kennedy Jr. “go wild” on health is demoralizing public health experts, who ...