More recently, the FDA posted two two letters: one backdated for September 9, regarding GSK’s HIV medication Apretude and one ...

Conditional approval extended through December 2026 for the treatment of CID in dogs CID confirmatory effectiveness trial expected to conclude in February 2026, ahead of FDA’s June deadline – 51 dogs ...

In a closely watched case, the U.S. solicitor general has urged the Supreme Court to review a controversy over so-called ...

Discover why Crispr Therapeutics AG is a strong buy with FDA-approved Casgevy, a promising pipeline, and major growth ...

Patients with statin resistance do not experience symptoms, Le noted. Instead, the problem is that statins do not lower LDL-C levels as much as they typically do. Instead of a 50% reduction, people ...

Pecorino romano cheeses from Boar’s Head and Locatelli have been recalled for potential listeria contamination. Here’s what to look for.

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 ...