Despite positive and sometimes emotional testimony from diabetes patients, an FDA advisory committee voted Thursday to uphold CDER’s recommendation that the new drug application for ITCA 650 (exenatide in DUROS…

In this edition of Quick Notes, we cover innovative medical devices including a mixed reality system for surgical navigation, robotic system for use in an MRI, a headband EEG and…

As lawmakers fail to reach a deal to extend funding past the critical deadline of Sept. 30, the possibility of a government shutdown looms, threatening operations at the FDA and…

Novartis’ recall of one lot of its Sandimmune oral solution (cyclosporine) due to crystal formation has been deemed a class 1 recall by FDA, the most serious type of recall,…

The FDA smacked Novo Nordisk, producer of blockbuster weight loss drug semaglutide, the active ingredient in Wegovy and Ozempic, for quality control deficiencies discovered at its Clayton, N.C., plant, including…

Companies selling unapproved biologics products is a major ongoing concern for the FDA’s CBER, says an agency consumer safety expert, speaking at the 2023 PDA/FDA Joint Regulatory Conference on Wednesday.…

Medline Industries’ recall of 18,000 saline solution vials due to being non-sterile has been deemed as class 1 by the FDA, the most serious type of recall, because use of…

Eli Lilly has filed 10 patent lawsuits against wellness clinics, med spas and compounders and pharmacies for marketing and selling unapproved versions of the company’s blockbuster Type 2 diabetes drug,…

The FDA has issued two draft guidances focused on requirements for drug and biological approvals — one on formal meetings and one on alternative methods the agency may use to…

Much needs to be hammered out before the FDA can comfortably green light first-in-human studies of artificial womb devices for extremely premature infants, said several members of the FDA’s Pediatric…