Scientists have found that lithium orotate — which is different from the kind of lithium typically used to treat mental health conditions — not only stopped the brain disease in mice but also reversed ...

National shareholders rights firm Hagens Berman continues to investigate the lawsuit's legal claims and urges Sarepta investors who suffered substantial losses to submit your losses now . The firm ...

Sarepta and Capricor learned of key regulatory decisions from the media and investors, and Duchenne muscular dystrophy ...

Vinay Prasad, a professor who until earlier this year headed a cancer-drugs and health-policy lab at UC San Francisco, ...

The FDA issued a complete response letter for Regeneron's lymphoma drug odronextamab. Elsewhere, Bristol Myers raised its guidance and analysts saw progress in Biogen’s turnaround.

Two major health agencies are facing leadership reshuffles, with the resignations of the FDA’s Vinay Prasad and NICE’s Dr Sam ...

PTC Therapeutics faces pivotal FDA decisions for approvals that could potentially transform their long-term revenues. Click ...

OH and the leaf of the kratom plant are not analogous, but as the former is a derivative of the latter, it has opioid-like qualities that make its susceptibility to abuse concerning.

Gene Therapy Market Gene therapy market surges on breakthroughs in genome editing, rising chronic & genetic disease cases, regulatory appro ...

Following a complete response letter rejecting accelerated approval for RP1 in advanced melanoma, IGNYTE trial investigators are urging the FDA to reevaluate the therapy’s robust survival data, just ...

The abrupt exit of the former CBER director raises questions about the FDA’s leadership. For now, newly appointed CDER head George Tidmarsh will take over Prasad’s post.

The FDA’s top vaccine and gene therapy official resigned amid heightened scrutiny over recent drug approval decisions and ...