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 ...
US FDA declines full approval for Intercept's liver disease drug
The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...
Nearly 80,000 pounds of Costco butter recalled for missing 'Contains Milk statement': FDA
Nearly 80,000 pounds of Costco butter was recalled because its packaging was missing the "Contains Milk statement." ...
MedPage Today2d
FDA Rejects Full Approval of Liver Disease Drug
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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 Care2m
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 ...
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.