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

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 ...

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

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

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

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 ...

Dining under palm trees on a patio at Mar-a-Lago in December, President-elect Donald Trump reassured chief executives at ...

The first half of 2025 was brutal for biotech, but investors are still keen on therapeutics in several indications and silver linings exist, particularly for private companies.  | The first half of ...

Nonetheless, Kennedy is still in charge of the entire department, and it is likely only a matter of time until he resumes ...

Sarepta Therapeutics has provided additional safety data on its gene therapy Elevidys as a Duchenne muscular dystrophy ...