News

Novo Nordisk Says FDA Accepted New Drug Application for Wegovy Pill
The Bagsvaerd, Denmark, company said that if the application is approved, Wegovy would become the first oral formulation of a ...
Exclusive: US FDA asks some fired pharma user fee negotiation staff to return
The U.S. Food and Drug Administration is asking some of its recently fired staff responsible for critically important funding ...
US FDA accepts Novo Nordisk's application for oral Wegovy for weight loss
The U.S. Food and Drug Administration has accepted Novo Nordisk's marketing application for an oral version of its ...
AI rules: FDA’s next step
Previous policy allowed up to a 12-month delay before articles were required to be made available to the public for free ...
GlobalData on MSN15h
FDA awards RMAT status to 4DMT diabetic macular oedema therapy
The therapy leverages the company’s intravitreal vector, R100, invented using the Therapeutic Vector Evolution platform.
In reversal, FDA rehires staff tasked with releasing public records
The FDA has rehired at least some workers tasked with releasing public records generated by the agency’s regulatory ...
The FDA suspended a milk testing program. Is it safe to buy & drink in NC?
Yes. Though the FDA has suspended its proficiency testing program, milk products are still safe to consume in North Carolina.
Clinical Advisor12h
FDA Commissioner: No Major Reorganization, Just Smart Reforms
"I have tremendous confidence in the many scientists, inspectors, and staff at the FDA to help accomplish these goals and am excited to work with them," said new FDA commissioner Dr Marty Makary ...
MyChesCo on MSN12m
FDA Approves Johnson & Johnson’s IMAAVY for Generalized Myasthenia Gravis
On Wednesday, the U.S. Food and Drug Administration (FDA) granted approval for IMAAVY™ (nipocalimab-aahu), Johnson & ...
CNET on MSN11h
Saying Bye to Red Dye No. 3: Learn Which Foods Still Use It and What to Expect Next
Linked to thyroid cancer in rats, Red dye No. 3 is now banned in the US -- but it'll take time to phase out completely.
MPR13h
FDA Clears Novel Wearable Defibrillator to Prevent Sudden Cardiac Arrest
The Food and Drug Administration (FDA) has cleared the Jewel ® Patch Wearable Cardioverter Defibrillator (Patch-WCD) for adult patients aged 18 years and older who are at risk for sudden cardiac ...