Food and Drug Administration

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FDA Has Big News on Postpartum Depression Front

Sage Therapeutics introduces fast-acting Zurzuvae, the first pill for condition afflicting new moms

(Newser) - Hundreds of thousands of women suffer from postpartum depression annually, and while the serious condition that emerges after childbirth often resolves within weeks, for other women, it can stretch for months, even years, and cause feelings that may even prove dangerous. Now, the Food and Drug Administration has announced a...

Influencer-Backed Energy Drink Has People Worried

Lawmakers want FDA to investigate PRIME

(Newser) - An influencer-backed energy drink that has earned viral popularity among children is facing scrutiny from lawmakers and health experts over its potentially dangerous levels of caffeine, the AP reports. On Sunday, Sen. Charles Schumer called on the Food and Drug Administration to investigate PRIME, a beverage brand founded by the...

Alzheimer's Drug Receives Experts' Support for Approval

Leqembi, which already has conditional OK, costs about as much as Aduhelm

(Newser) - Health advisers on Friday unanimously backed the full approval of a closely watched Alzheimer's drug, a key step toward opening insurance coverage to US seniors with early stages of the brain-robbing disease. The drug, Leqembi, received conditional approval from the Food and Drug Administration in January based on early...

FDA Has a New Rule for Gay, Bisexual Blood Donors

Gay, bisexual men in monogamous relationships can now donate without abstaining from sex

(Newser) - Gay and bisexual men in monogamous relationships can give blood in the US without abstaining from sex under updated federal health guidelines that focus on donors' behavior, not their sexual orientation. The Food and Drug Administration guidelines finalized Thursday ease decades-old restrictions designed to protect the blood supply from HIV....

FDA Issues Warning on Amniotic Fluid Eye Drops

Agency says products have not been approved

(Newser) - Amniotic fluid—the fluid that surrounds a fetus in the womb—is among the many things that you shouldn't put in your eyes, the Food and Drug Administration says. In a notification issued earlier this month, the agency said manufacturers are "marketing and distributing amniotic fluid eyedrops" for...

Misinformation Is Hurting Life Expectancy: FDA Chief

Robert Califf says Americans are being misled on more than COVID

(Newser) - Life expectancy is the US has been declining , including in relation to comparable high-income countries, and one federal official says part of the reason is the recent explosion of misinformation. "Why aren’t we using medical products as effectively and efficiently as our peer countries?" Robert Califf, commissioner of...

Abortion Pill's Fate Uncertain as Judges Face Off

Texas' Kacsmaryk orders hold on mifepristone access, Washington's Rice orders the opposite

(Newser) - Access to the most commonly used method of abortion in the US plunged into uncertainty Friday following conflicting court rulings over the legality of the abortion medication mifepristone that has been widely available for more than 20 years. For now, the drug that the Food and Drug Administration approved in...

FDA Approves OTC Narcan
You Will Be Able
to Buy Narcan OTC
Mar 29, 2023 8:41 AM CDT

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...

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