Upcoming events in the coming weeks and months include two FDA advisory committee meetings; MAGI 2024: The Clinical Research Conference; and webinars on overcoming common clinical trial challenges, supplier quality…
In 2022, FDA inspections of both foreign and domestic drug manufacturing plants were still far below pre-COVID-19 pandemic levels, although the number of citations soared, a new study has found.…
After agreeing this fall to participate in the Inflation Reduction Act (IRA) drug price negotiation program, AstraZeneca — whose type 2 diabetes therapy Farxiga (dapagliflozin) was among the first 10…
In this edition of Quick Notes, we look at expanded clearance for a smart watch, a retinal camera with designs on uncovering health problems, new software to better track neurological…
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…