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

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 ...

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

Two experimental oral obesity medicines from Novo Nordisk and Eli Lilly are moving toward potential FDA approval, raising legal and public-interest questions about access, regulatory oversight, and ...

Tarlatamab-dlle received FDA approval for ES-SCLC after showing a 40% reduction in death risk compared with chemotherapy in the DeLLphi-304 trial. The trial demonstrated improved overall survival ...

Sevabertinib received accelerated FDA approval for HER2 TKD-mutant nonsquamous NSCLC, showing a 71% ORR in the SOHO-01 trial. The treatment demonstrated a tolerable safety profile, with diarrhea as ...

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 ...

This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or 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 ...