The House Subcommittee on Health Care and Financial Services has asked the FDA to schedule a briefing with Committee staff no later than Dec. 11 to help with an investigation…

Aggressively using all the FDA’s regulatory flexibility to advance burgeoning treatments for rare diseases, particularly gene therapy, was a theme highlighted Monday by CBER Director Peter Marks. Source: Drug Industry…

Roche has announced the $2.7 billion acquisition of Carmot Therapeutics, including that company’s three potential incretin obesity and diabetes drugs. Source: Drug Industry Daily

As the public comment period closes Monday on the FDA’s rule to regulate laboratory-developed tests (LDT), the FDA has received more than 2,100 remarks — including hundreds in opposition that…

Recalled glucose capsules marketed as a health supplement for blood glucose control were found to contain glyburide and metformin — drugs that treat type 2 diabetes by lowering blood sugar…

The FDA announced changes to the organizational structures of Center for Biologics Evaluation and Research (CBER), Office of Blood Research and Review (OBRR) and the Office of Vaccines Research and…

As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and…

In an expansion of its investigation into suicidal ideation associated with GLP-1 agonists, the European Medicines Agency (EMA) wants manufacturers to answer some undisclosed questions about these drugs, while the…

In a strongly worded position paper, the European Commission’s Medical Device Coordination Group (MDCG) has directed device manufacturers to get certified ASAP under the new device and diagnostics regulations. Source:…

Leaks, breakage and other problems with plastic syringes manufactured in China have led the FDA to urge all users to check the manufacturing location of syringes and consider not using…