Lytgobi is an FGFR inhibitor that received accelerated approval in 2022 to treat adults with previously treated, unresectable ...

Office of Prescription Drug Promotion (OPDP) posted an untitled letter (the “Letter”)[1] that was issued on February 3, 2025 to Edenbridge DBA Dexcel (“Dexcel”) over allegedly misleading ...

In a highly unusual move, on March 27, the US Food and Drug Association (FDA) issued a Drug Safety Notice that calls into question both pending ...

Merck signed a licensing agreement for a heart disease drug with Jiangsu Hengrui Pharmaceuticals worth up to $2 billion.

AbbVie told Stat that it had stopped airing the ad after the first half of the year and that it is complying with the FDA's investigation. So-called 'untitled letters' from the FDA for advertising ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation ...

Dexcom made a significant design change to a component used in its sensors and did not adequately validate the change, ...

Dexcom, the local maker of continuous glucose monitors, received a warning letter from the Food and Drug Administration last week citing issues at two of its manufacturing facilities. The warning ...