Over the past week, the FDA issued guidance on its intention not to take action to enforce the requirements of DSCSA until Nov. 27, 2024, recommendations on system attributes necessary…

The FDA has deemed as class I another in a series of voluntary recalls from Getinge/Maquet/Datascope for various models of its Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pump (IABP),…

AdvaMed and the Medical Device Manufacturers Association (MDMA) commented this week on a CMS notice expediting Medicare coverage of emerging technologies, urging swift acceptance of the program, but also arguing…

Sen. Elizabeth Warren (D-Mass.) and Rep. Pramila Jayapal (D-Wash.) want the FDA to close loopholes that keep generic drugs off the market, they said in a recent letter to FDA…

FDA’s expedited regulatory programs cut up to two years off both clinical development and approval times for more than half of the drugs approved from 2015-2022, according to a new…

The FDA has deemed Hamilton Medical’s recall of certain of its ventilators as class I, the most serious type of recall as use the device may lead to serious injury…

The FDA issued Outlook Therapeutics a complete response letter (CRL) on its BLA for Lytenava (bevacizumab), an investigational ophthalmic formulation under development to treat wet age-related macular degeneration (AMD). Source:…

After inquiries about food, the FDA Office of the Ombudsman hears most often from device companies — because there are more small companies in that area of the industry —…

Novo Nordisk has acquired Embark Biotech, as the larger Danish drugmaker looks to expand its blockbuster obesity drug portfolio in the wake of surging economic demand and rising market shortages…

Our coverage spans a bone graft product that caused a tuberculosis infection, a subcutaneous cancer treatment, a warning letter for an eye drop manufacturer, 300 higher risk patients with a…