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FDA General

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FDA Adds Guillain-Barre Syndrome Warning to Two RSV Vaccines

Abrysvo and Arexvy labels will caution about risk of rare neurologic disorder

Jan 08, 2025
FDA SAFETY RSV vaccines Abrysvo and Arexvy over a computer rendering of a damaged myelin sheath.
FDA Limits Toxic Lead in Some Baby Foods

Guidance could reduce lead exposure by about 20% to 30%

Jan 07, 2025
A photo of the Food and Drug Administration building in Silver Spring, Maryland., Dec. 10, 2020.
FDA Unveils Draft Guidance to Improve Pulse Oximeter Accuracy Across Skin Tones

Agency recommends conducting larger studies with more patients from different racial groups

Jan 07, 2025
A photo of a healthcare worker using a pulse oximeter in Gauhati, India, Jan. 21, 2021.
CAR-T Warning for Secondary Malignancies: Warranted or Not?

FDA boxed warning led to multiple studies on the issue in 2024

Jan 05, 2025
A computer rendering of CAR-T cells attacking cancer cells.
CBD-Coated Tampons? FDA Says No Way

Agency also warns about Daye's vaginal microbiome screening kit

Jan 03, 2025
A photo of Daye hemp+cotton pads.
Opinion
Will the Trump Administration Be a Dangerous Ally to the Wellness Industry?

Several nominees may pose a threat to evidence-based public health

Jan 03, 2025
A photo of Mehmet Oz, MD.
Diversity Reporting Improved in Pulse Oximetry Testing After FDA Guidance

Most device records did not include information about performance testing in different skin tones

Dec 30, 2024
A photo of a woman wearing a pulse oximeter while lying in a hospital bed.
Have the New Pulmonary Hypertension Drugs Changed the Game?

Macitentan/tadalafil and sotatercept approvals shifted the field, but by how much seems to differ

Dec 29, 2024
 A computed tomography angiography scan of the pulmonary arteries.
GLP-1 Agents and Suicide: Making Sense of 2024's Mixed Data

Research should be interpreted cautiously, says researcher

Dec 28, 2024
 A photo of a woman holding an injection pen.
FDA Proposes New Testing Rules to Ensure Cosmetics Are Asbestos-Free

Proposal comes after years of lawsuits alleging links between talc-based baby powder and cancer

Dec 27, 2024
A photo of the FDA headquarters building as seen behind FDA logos at a bus stop on the agency’s campus.
Opinion
Eat, Drink, and Be Wary

What does the future hold in the wake of recent foodborne fiascos?

Dec 27, 2024
A photo of shoppers in a busy supermarket.
FDA Says Decongestant in Many Cold Medicines Doesn't Work. So What Does?

A look at the agency's recent moves on a leading decongestant

Dec 26, 2024
A photo of a person holding a decongestant pill containing phenylephrine.
First Generic of Once-Daily GLP-1 Injection Approved for Diabetes

Generic liraglutide approved at dosage for type 2 diabetes only

Dec 23, 2024
FDA APPROVED Generic liraglutide (Victoza) over a photo of a man self-injecting diabetes medication.
FDA Approves First Sleep Apnea Drug

Tirzepatide ok'd for obstructive sleep apnea in people with obesity

Dec 20, 2024
FDA APPROVED tirzepatide (Zepbound) over a photo of a sleep apnea mask.
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