Mike Pence's think tank is asking the Food and Drug Administration to turn over documents related to the dangers of the ...

Sarepta and Roche face a regulatory setback as the EMA's CHMP issues a negative opinion on Elevidys for Duchenne muscular ...

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and ...

In recent years, Artificial Intelligence (AI) has made significant strides across various sectors, providing innovative solutions and enhancing efficiency. However, ...

The FDA has accepted the resubmitted BLA for tabelecleucel (tab-cel), intended for the treatment of Epstein-Barr virus ...

Xuewu Liu, a Chinese inventor who has no medical training or credentials of any kind, is charging cancer patients $20,000 for ...

Despite a new setback for Elevidys in Europe, Roche—which markets Sarepta’s gene therapy outside the U.S.—remains committed ...

Tabelecleucel, an allogeneic, EBV-specific T-cell immunotherapy, works by targeting and eliminating EBV-infected cells.

A high dose of centanafadine was shown to be safe and effective at lowering ADHD symptoms for adolescents, according to ...

Cat’s-claw, chaparral, and blue-green algae (spirulina) supplements for rheumatoid arthritis may do more harm than good.

The CHMP’s recommendation for ZURZUVAE will now be reviewed by the EC for marketing authorization in the European Union with a final decision expected in the third quarter of 2025. The U.S. FDA ...