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 ...

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 ...

Far-right activist Laura Loomer is flexing her influence with the White House as she racks up policy and personnel wins from ...

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

The clinical hold is due to questions about BX004’s nebulizer device, temporarily pausing US enrollment in the cystic ...

The regulatory body determined that PTC Therapeutics’ New Drug Application for vatiquinone did not provide sufficient ...