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FBIO stock surges 12% pre-market after it wins FDA approval for rare pediatric Menkes disease

The FDA’s green light comes after Sentynl Therapeutics, fully owned by Zydus Lifesciences, assumed responsibility for ...
JD Supra

Illuminating the Risks: FDA Clearance Does Not Fully Shield Health & Wellness Devices from Advertising Scrutiny

The surge in health and wellness devices—including wearables, beauty devices and more—comes a result of consumer interest in preventive health measures. These products offer a range of benefits, from ...
Manila Standard

FDA reports 2025 milestones, reforms enforcement plans

The Food and Drug Administration (FDA) capped 2025 with a year-end report on Thursday, highlighting reforms, enforcement ...
MobiHealthNews

Tidepool head details pre-cert discussions with FDA, encourages industry participation

Last September, Tidepool — a diabetes data management platform — was among the nine companies chosen to participate in the FDA’s experimental pre-certification program pilot. Along with Apple, Samsung ...
National Academies of Sciences%2c Engineering%2c and Medicine

Ranking FDA Product Categories Based on Health Consequences, Phase II

With the responsibility to ensure the safety of food, drugs, and other products, the U.S. Food and Drug Administration (FDA) faces decisions that may have public-health consequences every day. Often ...