Indivior PLC (Nasdaq/LSE: INDV) provides the following update regarding its PDUFA action date for label changes (rapid initiation protocol and alternative injection sites) for SUBLOCADE® ...

Emblaveo marks the first and only fixed-dose intravenous monobactam/β-lactamase inhibitor combination antibiotic to be ...

Travere’s stock price climbed by 14% following the announcement it will seek an FDA label expansion for Filspari.

The U.S. Food and Drug Administration has approved Axsome Therapeutics' Symbravo (meloxicam and rizatriptan) for the acute ...

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

Shares of SpringWorks Therapeutics, Inc. (Nasdaq: SWTX) climbed 2.7%, building on a previous gain of 2%, following the FDA ...

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

FDA published a final version of its guidance document, “Communications From Firms to Health Care Providers Regarding ...

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

We think the strategy to find more effective combination therapies in hematology and build a larger oncology and dermatology portfolio is solid, although we're waiting for key data before assuming the ...

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

The telehealth company Hims & Hers put out a Super Bowl ad that skimped on clarifying that its compounded semaglutide medications aren't FDA-approved.