The United States Food and Drug Administration (USFDA) has issued a warning letter to Hyderabad-based online retailer ...
After debuting on the public markets with $256.3 million and raking in an additional $472 million, Veradermics has emerged as one of biotech’s biggest post-IPO standouts. CEO Reid Waldman credits the ...
How new review policies, the use of AI and other recent FDA changes are being impacted by high turnover at the top.
On June 22, 2026, the U.S. Department of Health and Human Services (HHS) announced the launch of Operation TrialBlazer, a coordinated effort ...
Cemdisiran, a potential new drug for the treatment of generalized myasthenia gravis, has been accepted for priority review by ...
The US Food and Drug Administration (FDA) revised its compliance program guide (CPG) for preapproval inspections (PAIs) for new drugs. This update emphasizes a risk-based approach to making decisions ...
Gore & Associates announced that the FDA approved updated labeling for the Gore Excluder abdominal aortic aneurysm (AAA) ...
The newly approved over-the-counter CGM offers a new approach to tackling childhood obesity but also raises a host of ...
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has ...
Marketed for longevity and wellness benefits, the unproven therapies are sold through a grey market online. Compounding ...
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