New FDA rules for TV drug ads: Simpler language and no distractions
FDA’s requirement for truthful, balanced risk and benefit information applies to drugmakers, leaving a loophole for both ...
Taco Recall in 31 States As FDA Sets Risk Level Over Listeria Fears
The Kroger Co. announced a recall in October for its Home Chef Chicken Street Tacos due to potential listeria contamination.
Reuters17h
US FDA approves PTC Therapeutics' gene therapy for ultra-rare disorder
PTC Therapeutics' gene therapy is already approved in the European Union, Great Britain, and Israel. The drugmaker will also ...
FDA Recalls Costco Butter for a ‘Peculiar’ Reason—Here’s What to Know
Save the addition of salt, spices and other add-ins for taste, butter is a single-ingredient food. So, it may come as a ...
Healthcare Policies to Watch in the New Trump Administration
Investors and entrepreneurs will track decisions affecting drugs, medical devices and telehealth.
Repurposed FDA-approved drug could uncover potential treatment for rare genetic disorders
In a new study, researchers at McMaster University have identified a potential treatment for Sandhoff and Tay-Sachs ...
The American Journal of Managed Care11m
FDA Approves Gene Therapy to Treat AADC Deficiency
The approval marks the first time gene therapy will be available to treat patients with aromatic I-amino acid decarboxylase ...
PTC Therapeutics wins FDA nod for gene therapy
PTC Therapeutics (PTCT) stock on watch as company receives FDA approval for gene therapy Kebilidi for AADC deficiency. Read ...
medtechdive15m
GE Healthcare’s head-only MRI scanner cleared by the FDA
The system is designed to shorten scan times, which may be better for people who struggle to stay still or have ...
emjreviews.com16h
FDA approves first gene therapy delivered directly to the brain
“We look forward to bringing this transformational gene therapy to children and adults with AADC deficiency.” The FDA ...
News Medical18h
The benefits and challenges of FDA Fast-Track and Accelerated Approval in drug development
The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs ...
STAT18h
FDA is still struggling with a lack of inspectors, but doesn’t have a plan, watchdog finds
A key reason positions haven't been filled is that they require travel that ranges from 25% to 75% of the time.