GH Research is scheduled to update on the FDA status of GH001 and outline its global Phase 3 plans for treatment-resistant ...

The FDA issued a CRL for ONS-5010, citing the need for additional confirmatory efficacy evidence despite previous trials ...

Just before the end of 2025, an oral version of a GLP-1 drug specifically used for weight management moved much closer to reality. On December 22, the U.S. Food and Drug Administration (FDA) approved ...

The U.S. Food and Drug Administration has updated the risk level for a major recall of shredded cheese products. Thousands of pounds of shredded cheese distributed by Great Lakes Cheese Co. Inc. were ...

Omeros (OMER) stock in focus as the FDA approves its lead asset as Yartemlea for a complication related to stem cell ...

A Boxed Warning was included in the prescribing information highlighting the risk of serious liver injury and acute liver failure. The Food and Drug Administration (FDA) has approved new safety ...

Ali Mahdavi - Spinnaker Capital Markets Inc. Scott McAuley - Paradigm Capital Inc., Research Division Greetings. Welcome to Spectral Medical Year-end 2025 Corporate Update End Year Review Call.

The Food and Drug Administration approved Merck's Keytruda in combination with Padcev to treat certain adults with muscle invasive bladder cancer (MIBC). The FDA said Friday it has approved the drug ...

ORLANDO, Fla. — The U.S. Food and Drug Administration is planning to change its vaccine approval process. The move comes after the release of a memo from a senior official that claims at least ten ...

Bubs shares are back in focus after a US update confirmed FDA engagement, ongoing sales access, and steady approval progress.