An FDA warning letter about the wearable company’s blood pressure feature raises questions as the lines between medtech and ...
In early December 2025, Scholar Rock reported that reported that the Novo Nordisk Bloomington, Indiana site (formerly Catalent Indiana LLC) received an FDA warning letter, while the company still ...
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its ...
The US Food and Drug Administration (FDA) has hit Philips with a warning letter after quality control shortcomings were uncovered at three of its medical device manufacturing sites. Issued on ...
The FDA sent warning letters in June to the facility owners, Shaman Botanicals LLC and Relax Relief Rejuvenate Trading LLC, ...
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or ...
The latest untitled letter from the FDA’s Office of Prescription Drug Promotion zeroes in on a patient testimonial video about Daiichi Sankyo’s tenosynovial giant cell tumor (TGCT) treatment, Turalio.