And finally, the agency is making plans to pull it from pharmacy and grocery store shelves.The medicines will remain ...
The US Food and Drug Administration (FDA) approved a new oral antibiotic to treat uncomplicated urinary tract infections ...
Though the company provided some records, FDA noted that these documents lacked clarity and approval by qualified FSVP personnel. Paso Real Produce LLC, based in Pharr, TX, received an FDA warning ...
Robert F. Kennedy Jr., the anti-vaccine conspiracy theorist Donald Trump promised would be given free rein over America’s ...
Lexicon Pharmaceuticals shares have been halted all day as a Food and Drug Administration advisory committee was scheduled to vote on Zynquista as an adjunct to insulin therapy for glycemic control in ...
Recently, the United States Food and Drug Administration (FDA) issued a draft guidance, Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice ...
The FDA continues to approve new drugs and expand indications for others at a rapid pace. Here’s a summary of what happened ...
In a Q&A, an FDA spokesperson discusses efforts to reduce misinformation about biosimilars through education, the agency’s ...
Younger patients in the U.S. can now benefit from Grifols Fibrin Sealant (FS) and its positive effect on surgical outcomes, including a fast time ...
RYTELOâ„¢ (imetelstat) is FDA approved for the treatment of low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent ...
In the briefing documents, FDA's reviewers again raised concerns ... The SGLT1/SGLT2 inhibitor last year gained approval (marketed as Inpefa) to reduce the risk of cardiovascular death and urgent ...