The FDA Adverse Event Reporting System, which Commissioner Marty Makary called “clunky,” previously published updates on a ...

The mad rush for safe and effective obesity drugs has winners—including Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy—and ...

There’s still much more to come from the White House on tariffs, but the European Union has now reached a trade agreement ...

Vanda claims that two generics to its sleep disorder drug Hetlioz were approved despite inadequate data and is requesting ...

With results from highly anticipated trials of Eli Lilly’s orforglipron and Viking Therapeutics’ VK2735 “underwhelming” ...

Krystal Biotech's decision follows the FDA’s rejection last month of Replimune’s RP1, which works similarly to Krystal ...

The FDA has identified critical lapses at a production facility operated by Novo Nordisk that is used by several drugmakers, ...

The FDA recommends that companies use overall survival as a primary endpoint for clinical trials where feasible. The new ...

In Phase III studies, Tonmya showed significantly superior analgesic effects in patients with fibromyalgia versus placebo.

Dawnzera is the first and so far only RNA-targeting therapy approved as a prophylactic treatment for hereditary angioedema ...

The small molecule, vatiquinone, had already flunked a Phase III trial, but the company pushed ahead with an approval bid ...

Capricor Therapeutics met with the FDA last week for a type A meeting, during which CEO Linda Marbán aimed to explain to the ...