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

The FDA has approved Linzess (linaclotide) for treatment of irritable bowel syndrome with constipation (IBS-C) in patients 7 years of age and older.

Some experts cited the case of Slentrol, an older weight loss drug for dogs made by Pfizer’s animal health division (which ...

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 ...

Based on this analysis, all 3 gepants are not cost-effective compared with usual care for the treatment of acute migraine. Objective: Migraine is a debilitating chronic disorder requiring multifaceted ...

Pfizer has launched Rimegepant ODT, a new migraine treatment in India. It offers rapid, lasting relief and targets patients who do not respond to conventional drugs. The medication dissolves without ...

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 ...