The U.S. Food and Drug Administration (FDA) has upgraded a recall of tomatoes sold in three southern states to a Class I recall, the most serious level, because the tomatoes may be contaminated ...

Colorado health providers cheer the approval but say the drug costs $14,000 per shot. Yeztugo is the first and only injectable HIV prevention medication.

FDA approval is supported by data from ASPIRE, a prospective, single-blinded, multi-center, randomized, controlled pivotal PMA IDE study, evaluating the safety and efficacy of PearlMatrix Bone ...

The FDA based its approval on results from the LIBERTY-BP ADEPT (NCT04206553) phase 2 and 3 study, which found dupilumab effective for adults with moderate to severe bullous pemphigoid and met ...

The FDA has quietly authorized more than 1,000 medical devices incorporating artificial intelligence or machine learning, marking a significant growth of AI in healthcare. The agency’s AI/ML ...

The FDA has approved a new, twice-yearly PrEP injection from pharmaceutical giant Gilead. The drug is lenacapavir. The twice-yearly formulation has the brand name Yeztugo.

Opinion How we plan to cut FDA drug approval time by months Qualifying manufacturers will be able to submit some data while clinical trials are ongoing.

Paige Spiranac ‘Niche’ Gets Nod of Approval from Annika Sorenstam. (Image Collage | Credits: Getty Images) Getty Images Speaking to Fox News Digital, Sorenstam gave her stamp of approval to ...

About KISQALI® (ribociclib tablets) KISQALI was previously approved by Health Canada on March 2, 2018, for the treatment of patients with HR+/HER2- advanced or metastatic breast cancer. 20 ...

Grail plans to include the Pathfinder 2 data in an FDA application for an updated version of the Galleri test, alongside results from a separate study being conducted with the U.K. National Health ...

A24 has strengthened its U.K. office with another poaching of senior executives from the local industry. Laura Lankester and Will Johnston, co-CEOs of Lookout Point, the BBC Studios-owned company ...