The FDA recommends that companies use overall survival as a primary endpoint for clinical trials where feasible. The new ...

Dr Vinay Prasad will return to head the FDA’s Center for Biologics Evaluation and Research less than 2 weeks after being ousted.

Capricor Therapeutics met with the FDA last week for a type A meeting, during which CEO Linda Marbán aimed to explain to the ...

A well-connected drug company and Laura Loomer wanted Kennedy ally Vinay Prasad gone. Trump chief of staff Susie Wiles got ...

No matter what regulatory decisions Dr. Vinay Prasad makes moving forward, the fact that he was willing to legitimize and ...

Therapies for rare and deadly disease are dying in Marty Makary’s shop.

Robert F. Kennedy’s right-hand man was briefly Laura Loomer’s latest scalp, but had his job saved thanks to the intervention ...

He’s using Biden-era mistakes to tarnish a promising technology.

Rocket’s relatively quick reprieve is good news for the stock, and suggests that the FDA remains actively supportive of gene ...

For more on Prasad’s return, go here; for a “Matt’s Take” on Prasad, go here; for the latest on investors’ attitudes toward ...

A handful of drug companies have formed a group to present lawmakers with research on the negative impacts of Medicare drug ...

The company plans to continue with a lower dose and a change in the pre-treatment regimen after a trial participant died ...