Researchers explored the potential of Prunus laurocerasus (cherry laurel) and Prunus cerasifera (cherry plum) fruit pits as ...
Built around the beginning of the 1st century BCE, the Antikythera Mechanism is the oldest known analog computer in human history, and there’s an enduring mystery surrounding what it was used for. In ...
Personalized genetic interventions like antisense oligonucleotides and genome editing can help children with rare diseases, but it has been difficult for manufacturers to get regulatory approval for ...
The Food and Drug Administration Monday unveiled the details of a new policy designed to make it easier and quicker for patients with very rare diseases to get cutting-edge treatments. The new ...
After teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...
Jason Mast is a general assignment reporter at STAT focused on the science behind new medicines and the systems and people that decide whether that science ever reaches patients. You can reach Jason ...
The mechanism of action of Wegovy (how it works) may vary depending on the indication(s) for which it is prescribed. Here is what experts know about Wegovy’s mechanism of action for its approved uses.
Panelists discuss how the muscarinic pathway of xanomeline/trospium offers a safer, nondopaminergic approach to schizophrenia care. Panelists discuss how xanomeline/trospium chloride introduces a ...
The US Food and Drug Administration (FDA) is proposing a new “plausible mechanism” pathway that will enable the limited approval of bespoke therapies when randomized trials are impractical. FDA will ...
In a highly anticipated article, FDA officials Vinay Prasad, M.D., and Martin Makary, M.D., outlined a novel regulatory pathway that could trigger a seismic shift in how bespoke gene editing therapies ...