Shares in Sarepta reversed some of their recent declines after the FDA added a warning label to its Duchenne muscular dystrophy (DMD) gene therapy, ending a protracted period of uncertainty for the ...

The drugs are essentially laboratory-made versions of natural antibodies that help the immune system fight off RSV. The FDA ...

To continue reading this content, please enable JavaScript in your browser settings and refresh this page. Preview this article 1 min The FDA has restricted the ...

Pharmacokinetic and safety studies were analyzed to demonstrate the safety and efficacy of TRN-257, as well as previous research on oxybate products.

Company addresses FDA requests regarding formulation excipient – Global site start-up activities continue, with first-patient-in for ...

To continue reading this content, please enable JavaScript in your browser settings and refresh this page. Preview this article 1 min The FDA has restricted the type ...

Alert FDA Approves Third-Ever Drug for Lupus Nephritis Obinutuzumab (Gazyva) is the first drug to be approved for lupus nephritis since the approvals of belimumab (Benlysta) in 2020 and voclosporin ...

Jelly Roll, Ashley Tisdale, Chrissy Teigen, Meghan Trainor and more celebs who've talked about semaglutide drugs including Ozempic and Wegovy — and where they fall on its usage Kate Hogan was Director ...

Alert Rejected cGvHD Therapy Gets Second Look by EMA The EMA initially rejected Rezurock due to uncertainty over its clinical benefit, noting that the pivotal study had no comparator arm and permitted ...

Microdosing GLP-1 weight loss drugs like semaglutide is trendy, with supporters touting benefits such as lower costs and potentially fewer side effects. But some doctors are skeptical, calling it ...