The FDA has approved an expanded label for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which ...

Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...

The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its ...

On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms ...

Advocates say microdosing reduces costs and side effects while maintaining weight loss, then can help with weight maintenance ...

Three strikes and you’re out? Not for Supernus Pharmaceuticals and its Parkinson’s disease infusion pump. | The device is ...

Day One Biopharma's OJEMDA FDA approval for pediatric glioma, but market concerns remain. Check out why I rate DAWN stock as ...

Librela (bedinvetmab injection) is a monthly injectable monoclonal antibody, for which real-world drug experience data has ...

Morgan Stanley analyst Erin Wright views the latest label change for Librela as “encouraging,” offering vets clarity in prescribing, and while ...

Eli Lilly And Cao (NYSE:LLY) announced the results from the VIVID-2 open-label extension study of Omvoh (mirikizumab-mrkz).

Zoetis (ZTS) announced that it has updated the U.S. label for Librela, following its submission of a supplement to the FDA. This supplement ...

The Vivacity-MG3 study is currently in its open-label extension phase, which is investigating the longer-term safety and ...