The FDA has completed its review of the investigational new drug application (IND) for PSV359, and issued a "study may proceed” letter in 1Q 2025. Site activation activities are underway, with the ...

The family of a 91-year-old Maine woman sued Glenmark in federal court in Newark, New Jersey, last year, alleging the company ...

The evolution of the safety and effectiveness evaluation of endovascular grafts intended for abdominal aortic aneurysm repair ...

FDA grants Fast Track designation to Johnson & Johnson’s investigational therapy nipocalimab for the treatment of moderate-to ...

RedHill plans to submit UK MAA1 for Talicia for H. pylori infection, using MHRA's2 new fast-track approval process, referencing FDA approval, with potential UK approval ...

Per the FDA's request, the first five patients enrolled will receive ... and can be viewed here. In concert with the observation of prolonged survival in patients with mTNBC described above, CytoDyn ...

Languages: English. Two children's Babyganics sunscreen products have been classified as a Class II recall by the Food and Drug Administration (FDA), raising concern about the product's safety for ...

The Sixers entered Friday with 15 players on their standard roster. 11 of those players wound up being unavailable for the night's home game against the Indiana Pacers, due to injuries and illnesses.

Pharmaceutical company Alkem Laboratories Ltd on Thursday (March 13) announced that the United States Food and Drug Administration (US FDA) conducted a Bioresearch Monitoring (BIMO) inspection at its ...

Recent FDA feedback received on SER-155 allogeneic hematopoietic stem cell transplant (allo-HSCT) next study provides support for the proposed ...