Healio2h
FDA grants priority review to oral non-small cell lung cancer drug
The FDA granted priority review to a new drug application for sunvozertinib as an oral treatment for certain patients with ...
Hosted on MSN1d
Is It COVID or the Flu? Take This FDA-Approved, At-Home Test to Find Out
You don't need a prescription to purchase a test that will tell you whether you're sick with COVID or the flu.
Health Advocates Are Unhappy with FDA Guidance on Lead Levels in Baby Food
TUESDAY, Jan. 7, 2025 (HealthDay News) -- The U.S. Food and Drug Association (FDA) released the first-ever guidelines for ...
BioSpace23h
When Are Confirmatory Trials ‘Underway’? FDA Releases New Accelerated Approval Guidance
Amid recent backlash stemming from market withdrawals and trial delays, the FDA seeks to further clarify its requirements for ...
STAT1d
FDA releases long-awaited guidance to improve accuracy of pulse oximeters for all skin tones
Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should use ...
FDA sets limits for lead in many baby foods as California disclosure law takes effect
The FDA has set maximum levels for lead in baby food. A new California law requires baby food makers selling products in the ...
FDA issues first draft guidance on use of AI in drug, medical device development
Recognizing the increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released ...
BioSpace2d
5 FDA Decisions to Watch in Q1
Among the FDA’s pending decisions for this quarter are Vertex’s non-opioid pain drug and Sanofi’s RNA interference therapy ...
FDA proposes new testing rules to ensure cosmetics are asbestos-free
The Food and Drug Administration is proposing a rule that cosmetic companies would have to take extra steps to ensure that ...
McKnight's Long-Term Care News12d
FDA approves Zepbound for sleep apnea in patients with obesity
The US Food and Drug Administration has approved Zepbound (tirzepatide) as the first prescription medication for the treatment of obstructive sleep apnea (OSA).
Rezolute Receives Breakthrough Therapy Designation from FDA for Ersodetug in the Treatment of Hypoglycemia Due to Congenital Hyperinsulinism
Breakthrough Therapy Designation granted based on key positive data from the Phase 2b (RIZE) study and current unmet medical need in congenital ...