The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for TRN-257, a controlled-release, low-sodium oxybate product, for the treatment of c ...

The U.S. Food and Drug Administration has approved an updated label for Unloxcyt (cosibelimab-ipdl) for the treatment of ...

The drugs have soared in popularity, with some men taking them for unapproved uses like anti-aging or increasing muscle mass.

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 ...

Promo materials should also refrain from positioning one approved biosimilar as better than another for the same reference product, per the document, and they shouldn’t suggest that a biosimilar is ...

The U.S. Food and Drug Administration has approved an expanded indication for Eli Lilly's Jaypirca (pirtobrutinib), the first and only noncovalent Bruton tyrosine kinase (BTK) inhibitor for adults ...

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 ...

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 ...

Following the expanded approval, the accelerated approval for the later-line CLL/SLL was converted to a traditional approval.

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 ...