FDA Coverage

FDA approves two gene therapies for sickle cell, bringing hope to thousands with the disease

(CNN) — The US Food and Drug Administration on Friday approved two gene-based treatments for sickle cell disease, including the first therapy that uses the gene-editing technique CRISPR, opening a new era of treatments for genetic Whether people will be able to afford and access these treatments, though, is a key question. One-time genetic treatments typically carry price tags of upwards of $1 million each and require the infrastructure of large medical systems..

By Meg Tirrell, CNN

Recalled applesauce pouches still on some store shelves, FDA says, as more illnesses reported

(CNN) -- Cinnamon applesauce pouches that have been recalled after reports of high blood lead levels in children are still on the shelves at some Dollar Tree stores, the US Food and Drug Administration said Wednesday.

By Katherine Dillinger, CNN

Gravy recalled: Jars from Hy-Vee may contain soy not listed on labled

The company issued a precautionary recall on Wednesday because the gravy may contain soy, which is not listed in the ingredients on the label.

FDA bans Balance of Nature supplements, judge orders company to stop selling & manufacturing

Supplements sold by Walmart and Amazon are being pulled off the market because of unsupported claims that they can prevent, treat and cure diseases such as cancer.

34 reports of ilness linked to recalled cinnamon applecauce pouches

There are currently 34 reports of illness potentially linked to the recall of WanaBana Apple Cinnamon Fruit Puree and two other similar products.

FDA bans Balance of Nature supplements

Supplements sold by Walmart and Amazon are being pulled off the market because of unsupported claims that they can prevent, treat and cure diseases such as cancer.

Grifols receives FDA approval for new plasma-related facility in Clayton

Grifols, a global leader in plasma medicines, has received approval from the U.S. Food and Drug Administration for its new immunoglobulin (Ig) purification and filling facility at its Clayton manufacturing campus, one of the world’s largest sites for producing plasma-derived medicines.

Dog food recalled due to salmonella contamination

Three brands of dog food have been recalled due to salmonella contamination or potential salmonella contamination.

Keely Arthur, WRAL consumer reporter

NCDHHS investigation reveals high lead levels in WanaBana apple cinnamon puree; recall issued

NCDHHS said it shared its finding with the FDA, which issued an advisory warning.

FDA: 2 companies sold illegal infant products to hospitals

The FDA has warned two companies they say have been illegally selling probiotic products for infants that could be dangerous, even deadly.

WRAL staff

FDA takes ‘momentous’ step toward banning menthol cigarettes and flavored cigars

(CNN) — The US Food and Drug Administration has taken a “momentous” step toward banning menthol in cigarettes and banning flavored cigars, sending final rules to the White House Office of Management and Budget for review, a key regulatory step. Public health experts say a menthol cigarette and flavored cigar ban could save hundreds of thousands of lives.

By Jen Christensen, CNN

CVS, Walgreens get warning letters for selling unapproved eye drops

The two largest pharmacy chains in the country are being warned to stop selling illegally marketed, unapproved drugs.

Mayo Clinic study results back bioengineered vessels, Humacyte reports

Peripheral artery disease affects around 1 in 20 Americans over the age of 50, occurring when blood flow is limited by blocked arteries. The patients were treated with the implantation of a Human Acellular Vessel (HAV), a bioengineered tissue, to from Humacyte to facilitate revascularization.

FDA approves antibody to protect infants from RSV

WRAL News asked local health experts about the FDA's approval of the new drug, which could help prevent many babies and toddlers from going to the hospital.

First over-the-counter birth control pill approved by FDA

Dr. Amy Bryant, an OB/GYN with UNC Health, discussed the nation's first over-the-counter birth control pill. On Thursday, federal regulators approved the pill in a landmark decision that will soon allow American women and girls to obtain contraceptive medication as easily as they buy aspirin and eyedrops.

FDA approves first over-the-counter birth control bill

Federal regulators on Thursday approved the nation's first over-the-counter birth control pill in a landmark decision that will soon allow American women and girls to obtain contraceptive medication as easily as they buy aspirin and eyedrops.

Horse tranquilizer mixed with Fentanyl poses new threat

Xylazine is popping up across the country, primarily detected after being mixed with opioids like fentanyl. The drug is typically used as a tranquilizer or sedative for horses.

UNC and Duke creating new Triangle research center to work with FDA

The Research Triangle Center of Excellence in Regulatory Science and Innovation (CERSI) will serve as an accelerator to meet the FDA's evolving need to access the most current scientific knowledge, and to also create a tight-knit community for regulators, academia, industry and other stakeholders.

FDA awards $50 million to Triangle universities for joint work on drug development process, regulatory oversight, public health information

The FDA expects the Triangle Center of Excellence in Regulatory Science and Innovation (CERSI) to provide "essential new information, as well as infrastructure and tools to shorten the drug and device development process, to advance public health and to inform regulatory decision making and guidance documents."

FDA awards $50 million to Triangle universities for joint work on drug development process, regulatory oversight, public health information

The Research Triangle Center of Excellence in Regulatory Science and Innovation (CERSI) will serve as an accelerator to meet the FDA's evolving need to access the most current scientific knowledge, and to also create a tight-knit community for regulators, academia, industry and other stakeholders.

Monica Casey, WRAL Durham reporter

FDA expected to give first full approval for Alzheimer's drug

Wednesday, for the first time ever, the FDA may give full approval to a drug designed to slow the progression of Alzheimer's disease.

FDA to decide Wednesday on approval of Alzheimer's drug Leqembi

Wednesday, for the first time ever, the FDA may give full approval to a drug designed to slow the progression of Alzheimer's disease.

FDA recommends updating COVID-19 vaccine

The FDA must decide what to include in the next round of booster shots for COVID-19.

Durham company grows human blood vessels, sends them to wounded Ukraine soldiers

A company at RTP is growing human blood vessels and sending them to help wounded soldiers in Ukraine.

Sarah Krueger, WRAL Sr. Durham reporter

FDA meeting today on over-the-counter birth control

Women may soon be able to get birth control pills over-the-counter. The FDA is meeting today to discuss next steps on what would become a historic move for millions of women in the U.S.