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

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

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

AAP published the new advice on Tuesday, saying it strongly recommends Covid shots for children ages 6 months to 2 years.

Frustration is reportedly mounting inside the Trump administration as senior officials grow increasingly suspicious of right‑wing provocateur Laura Loomer, with some branding her as “more trouble than ...

Delays from the Food and Drug Administration continue to pile up, with Maryland-based Regenxbio the latest to report the review of one of its assets ...

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

This first approved medical therapy for RRP generates an immune response against the causative HPV strains. It uses ...

The FDA approved the adenoviral vector-based immunotherapy, zopapogene imadenovec-drba, for treatment of certain patients ...

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

Precigen's immunotherapy for a rare respiratory disease has become the first treatment to win U.S. regulatory approval for ...

Precigen (PGEN) stock jumps as the FDA approves the company's gene therapy Papzimeos for adults with recurrent respiratory ...