The FDA accepts Axsome's resubmission of the NDA for AXS-07 for the acute treatment of migraine. A decision is due on Jan. 31, 2025. Shares rise.

In a significant enforcement action, the Maharashtra Food and Drugs Administration (FDA) has carried out a raid on Gynoveda Femtech Pvt. Ltd., an...

Imugene has landed a prized FDA orphan drug approval for its bile tract cancer therapy following positive results from its recent metastatic advanced...

Imugene has landed a prized FDA orphan drug approval for its bile tract cancer therapy following positive results from its recent metastatic advanced...

DNLI's recent meeting with the FDA was successful and provides the path to file for accelerated approval of tividenofusp alfa for the treatment of MPS...

DNLI's recent meeting with the FDA was successful and provides the path to file for accelerated approval of tividenofusp alfa for the treatment of MPS...

An international team of scientists from China, Denmark and the UK has analysed nearly 43.2 thousand genomes of marine microorganisms, discovering...

An international team of scientists from China, Denmark and the UK has analysed nearly 43.2 thousand genomes of marine microorganisms, discovering...

Another committee that’s getting the band back together after summer vacation is the Transit Advisory Committee. With everyone back at school,...

FDA approves J&J's Tremfya for ulcerative colitis. NVO's oral obesity pill, amycretin, shows faster weight loss than weekly injection, Wegovy.