FDA

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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...

FDA Advisers Support Full Approval of Paxlovid

Experts have cautions about drug interactions, rebound COVID-19 cases

(Newser) - Paxlovid is nearing full FDA approval for use against COVID-19 after the drug was endorsed by the agency's panel of advisers on Thursday. The drug has been employed under a Food and Drug Administration emergency use authorization for patients over 50 whose COVID case is considered at high risk...

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 Finally Gets Its Way on Drug It Wanted Pulled
FDA Finally Gets Its Way
on Drug It Wanted Pulled
the rundown
Mar 8, 2023 10:25 AM CST

FDA Finally Gets Its Way on Drug It Wanted Pulled

Covis, maker of Makena, will voluntarily remove its preterm birth drug from the US market

(Newser) - The number of drugs available to US women who've had a spontaneous preterm birth and are trying to prevent another once again stands at zero. Makena had been the sole drug on the market and was used by about 350,000 women over the last 10 years, but maker...

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...

For Those Seeking Abortion, This Is a 'Game Changer'

FDA finalizes rule change allowing certified pharmacies to dispense abortion pill mifepristone

(Newser) - The FDA on Tuesday approved a rule change allowing retail pharmacies to dispense the abortion pill mifepristone—providing more options for residents of states where abortion pills are allowed and for those able to travel out of states where abortion is restricted. The Biden administration broadened access to the drug...

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...

FDA Just Made a Huge Move on Hearing Aids

People will be able to get them over the counter, and probably for much cheaper

(Newser) - As soon as the middle of October, people will be able to walk into a store for the first time and buy over-the-counter hearing aids. It's the result of a rule finalized by the FDA on Tuesday, one expected to have profound effects on the market for such devices—...

Wait for the Next Booster, Officials Tell Adults Under 50

Moderna, Pfizer assure government updated omicron version will be ready for fall

(Newser) - Federal health officials have decided against approving a second booster shot of the coronavirus vaccine this summer for adults under 50, because a retooled version is so close to being ready. Pfizer and Moderna have assured the government their new boosters will be rolled out no later than September, the...

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'...

FDA Chief Takes Heat Over Infant Formula Shortage

Whistleblower's warning apparently languished in a mailroom

(Newser) - House members of both parties pressed the head of the Food and Drug Administration on Wednesday about how the infant formula crisis could have gotten this bad. "Why did it take an onslaught of national media attention for the Biden administration to act with a sense of urgency required...

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