For the first time, the US Food and Drug Administration has set a limit on the amount of lead that can be in baby foods, but critics say it’s too little, too late.

By the end of March, the regulator could clear a highly anticipated pain drug from Vertex and a heart drug that’s critical to Alnylam’s future.

Chimerix submitted a new drug application to the FDA seeking accelerated approval for dordaviprone to treat patients with ...

On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued a declaratory order determining that the shortage of diabetes and ...

After plugging billions into its manufacturing network to meet rampant demand for Mounjaro and Zepbound, Eli Lilly is looking ...

“As we entered 2024, the Company had three primary goals in our quest to ensure we are ready for the successful commercial launch of LIBERTY in 2025: 1) complete FDA 510(k) submission ...