FDA introduces guidelines for lead levels in processed baby foods, aiming to enhance infant safety and reduce exposure to ...

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

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.

Aquestive Therapeutics' Anaphylm is nearing FDA approval, potentially disrupting the U.S. anaphylaxis market dominated by ...

Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025Cyprium is eligible to receive royalties and up to $129 ...

“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 ...

A new drug application seeking the accelerated approval of dordaviprone forrecurrent for H3K27M-mutant diffuse glioma ...

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

Microbot Medical Inc. announces key milestones, including FDA 510(k) submission, in preparation for LIBERTY's commercial launch in 2025. Microbot Medical Inc. announced the successful completion ...

KOLLAM: In an effort to dismantle the drug trafficking network in the district, 96 cases were registered across various ...

Sequana Medical NV has announced the US FDA approval of its Alfapump system for treating recurrent or refractory ascites due to liver cirrhosis. This approval marks Alfapump as the first active ...