The agency recently sent a warning letter to the company's CEO, Valentina Milanova, noting that an inspection of the ...

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

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

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

Lexicon Pharmaceuticals has already thrown in the towel on its commercial efforts after a years-long uphill battle to get its ...

“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 ...

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 ...

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

The US Food and Drug Administration (FDA) has approved Sequana Medical’s alfapump for the treatment of recurrent or ...

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 ...