Food and Drug Administration

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FDA Approves OTC Narcan
You Will Be Able
to Buy Narcan OTC

You Will Be Able to Buy Narcan OTC

FDA gives the thumbs-up for drug to be sold over the counter

(Newser) - The FDA on Wednesday approved selling naloxone without a prescription, setting the overdose-reversing drug on course to become the first opioid treatment drug to be sold over the counter. It’s a move that some advocates have long sought as a way to improve access to a life-saving drug, reports...

Migraine Sufferers May Soon Have Their Very Own 'EpiPen'

FDA approves zavegepant, or Zavzpret, a fast-acting nasal spray designed to provide pain relief

(Newser) - A new nasal spray from Pfizer has just been OKed by the Food and Drug Administration, and the company hopes it will be a game changer for the nearly 40 million migraine sufferers in the US. Reuters reports on the FDA's Friday approval of zavegepant, sold under the brand...

FDA Makes Move Against 'Zombie Dope'

Xylazine, or 'tranq', increasingly found in illicit drug mixes, is subject of new import alert

(Newser) - The FDA is taking action to restrict unlawful imports of xylazine, an animal tranquilizer increasingly used in the illicit drug market , where it's commonly known as "tranq" or "zombie dope" due to its tendency to cause flesh to rot and die. Horror stories accompany the sedative, which...

FDA Wants to Keep Almond, Soy Drinks Called 'Milk'

Dairy producers have pushed for labeling changes

(Newser) - Soy, oat, almond, and other drinks that bill themselves as milk can keep using the name, according to draft federal rules released Wednesday. Food and Drug Administration officials issued guidance that says plant-based beverages don't pretend to be from dairy animals – and that US consumers aren't confused...

FDA to Make Big Move on Blood Donation Rules

No more automatic 3-month waiting for gay, bi men, per proposal

(Newser) - A big change looks to be coming to the Food & Drug Administration's long-criticized guidelines for blood donors as it relates to the LGBTQ community. Bloomberg reports that the agency is seeking to ease its restrictions on gay and bisexual men, who, under the current policy, have had to...

The FDA Has Just Approved a Drug That Costs $3.5M a Dose

Hemgenix is a one-time treatment for the blood-clotting disorder hemophilia

(Newser) - US health regulators on Tuesday approved the first gene therapy for hemophilia, a $3.5 million one-time treatment for the blood-clotting disorder. The FDA cleared Hemgenix: It's an IV treatment for adults with hemophilia B, the less common form of the genetic disorder, reports the AP . Currently, patients receive...

Thanks to FDA, Women Will Be Told of Their Breast Density

Those with dense breasts may want to do more than the standard mammogram

(Newser) - Women are told to start getting mammograms at 40. What they may not be told is what kind of breast density they have—though that's about to change, thanks to the FDA. It's no small detail: As Dr. Sarah Friedewald, the chief of breast imaging at Northwestern Medicine,...

Patients Griped About It. Now the FDA Confirms It

Agency makes it official: There's a nationwide Adderall shortage

(Newser) - There've been rumblings for months at some US pharmacies on difficulties obtaining Adderall. Now, official word from the Food and Drug Administration: There's a US shortage of the medication used to treat ADHD, reports NBC News . In a Wednesday release , the FDA announced the dearth of the drug,...

FDA: This Is a Really Bad Way to Cook Chicken

Agency issues warning on NyQuil challenge

(Newser) - The Food and Drug Administration wants Americans to know that cooking chicken in cough syrup is as bad an idea as it sounds. In an FDA warning about social media challenges, the agency referred to a TikTok video that showed somebody cooking chicken in NyQuil cough and cold medication, which...

For Birth Control Access in the US, a 'Groundbreaking Moment'

HRA Pharma submits application to FDA for nation's first over-the-counter birth control pill

(Newser) - Ever since the Supreme Court overturned Roe v. Wade last month, effectively banning abortion in states that choose to, reproductive rights advocates have worried that contraception might be the next target of conservative activists and lawmakers. One company is now trying to dismantle at least some of the barriers to...

Juul Actually Doesn't Have to Pull Its E-Cigs Yet

FDA temporarily suspends its order banning the products

(Newser) - The Food and Drug Administration issued an administrative stay Tuesday on the order it issued last month for vaping company Juul to pull its electronic cigarettes from the market. The agency said on Twitter that the stay temporarily suspends the marketing denial order while it conducts further review, but does...

Amid Criticism on FDA Response, News of a 3rd Infant Death

FDA says investigation is in early stages on baby said to have consumed Abbott baby formula

(Newser) - The FDA has learned about the third death of an infant who reportedly consumed Abbott Laboratories' baby formula, linked to bacterial contamination. The agency said it received a consumer complaint related to the January death on June 10, per the Wall Street Journal . It had already disclosed that four infants...

FDA Advisers Endorse Vaccines Starting at 6 Months

Age group is the only one without access to COVID vaccines in US

(Newser) - COVID-19 shots for US infants, toddlers, and preschoolers moved a step closer to reality on Wednesday. The Food and Drug Administration's vaccine advisers gave a thumbs-up to vaccines from Moderna and Pfizer for the littlest kids. The outside experts voted unanimously that the benefits of the shots outweigh any...

FDA Posts Analysis of Pfizer Shots for Kids Under 5

Says the kid-sized dose appears to be safe and effective

(Newser) - Update: The FDA on Sunday posted its analysis of Pfizer’s COVID-19 vaccine for children under age 5, announcing that the kid-sized doses do appear to be safe and effective. The agency posted a similar analysis of Moderna's vaccine for the youngest age group last week. Next up: Wednesday'...

Feds Are Preparing Plan to Ban Menthol Cigarettes
FDA Makes Big Move
to Curb Smoking
UPDATED

FDA Makes Big Move to Curb Smoking

Agency announces plan to ban menthol cigarettes

(Newser) - Update: The FDA on Thursday made one of its biggest moves in more than a decade to curb smoking by unveiling a plan to ban menthol cigarettes, reports the New York Times . Now comes a 60-day period for public comments, followed by any needed revisions. It could be at least...

The Mouse Infestation at FDA HQ Is Sort of Normal

It turns out mice, other critters are common around White Oak, but pandemic didn't help

(Newser) - It could happen in any office building from which staff made hasty, "temporary" departures at the start of the pandemic. One week rolled into the next, and the workers did not return, but all those snacks around their offices remained. Local rodents took notice, apparently, at the FDA's...

FDA Authorizes Second Booster for Ages 50 and Older

CDC will weigh in next on the extra COVID shots

(Newser) - Update: The FDA on Tuesday authorized a second booster shot for people ages 50 and older, reports the Washington Post . The Pfizer or Moderna shots won't be made available until the CDC weighs in, and the agency is expected to quickly back the extra booster for those whose first...

FDA Updates Baby Formula Warning After Second Death

Abbott's Similac, Similac Alimentum, EleCare from Mich. plant tied to deadly bacteria

(Newser) - Update: The Food and Drug Administration has updated its warning on infant formulas made at a Michigan plant after the death of another child. The FDA warned against using Similac PM 60/40 with lot code 27032K800 on the case and 27032K80 on the can, NPR reports. Manufacturer Abbott said in...

'Unacceptable' Visitors at Family Dollar Site Lead to Closures, Recall

Rat infestation at Ark. distribution center forces 400-plus stores to close in South, product recall

(Newser) - Bad news if you're a regular at Family Dollar and you're in the South: Chances are, a location near you may be shuttered temporarily after a rat infestation at an Arkansas distribution warehouse. The Washington Post reports that 404 stores in six states—Alabama, Arkansas, Louisiana, Mississippi, Missouri,...

Senate Narrowly Confirms Biden's FDA Pick

6 Republicans backed Califf in 50-46 vote

(Newser) - The Senate narrowly confirmed President Biden’s pick to lead the Food and Drug Administration on Tuesday, pushing past a thicket of political controversies that threatened to derail what was initially expected to be an easy confirmation. The 50-46 vote means Dr. Robert Califf, a cardiologist and prominent medical researcher,...

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