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

The American Academy of Pediatrics has released new Covid-19 vaccine recommendations for children which breaks with CDC guidelines for the first time in three decades. AAP published the new advice on ...

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 ...

Nonetheless, Kennedy is still in charge of the entire department, and it is likely only a matter of time until he resumes appointing resolute anti-vaxxers, if not widely discredited would-be ...

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

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 ...

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