FDA

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In Surprise Move, FDA Rejects Needle-Free EpiPen Rival

It wants ARS Pharmaceuticals to conduct additional research on its Neffy nasal spray

(Newser) - In a surprise move, the FDA declined to grant approval to a nasal spray that would be the first needle-free alternative to epinephrine autoinjectors—more commonly referred to by the brand name EpiPen. In May, the FDA's advisory committee voted to recommend approval of ARS Pharmaceuticals' Neffy. But in...

Latest COVID Vaccinations Could Begin This Week
You Can Now Get Your
Updated COVID Vaccine
UPDATED
Sep 13, 2023 12:41 AM CDT

You Can Now Get Your Updated COVID Vaccine

Shots beginning this week, as soon as Wednesday in some locations

(Newser) - Most Americans should get an updated COVID-19 vaccine, health officials said Tuesday. Advisers to the Centers for Disease Control and Prevention endorsed the new shots for everyone 6 months and older and the agency's director quickly signed off Tuesday on the panel's recommendation. That means doses should be...

Popular Nasal Decongestant Doesn't Work, Says FDA Panel

Products with phenylephrine, or PE, won't help your stuffy nose, say advisers

(Newser) - The leading decongestant used by millions of Americans looking for relief from a stuffy nose is likely no better than a dummy pill, according to government experts who reviewed the latest research on the long-questioned drug ingredient. Advisers to the Food and Drug Administration voted unanimously on Tuesday against the...

Some Think It's High Time to Improve US Sunscreen

AOC is among those trying to nudge Congress and the FDA

(Newser) - Nearly a decade ago, Congress got interested in improving the quality of sunscreen in the US, which is generally considered sub-par when compared to products offered elsewhere in the world. The result in 2023: Not much has happened. Now the interest is percolating again, as evidenced in an Instagram video...

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...

Drug to Protect Babies From RSV Gets Green Light

FDA approves drug to ward off respiratory virus that kills hundreds of kids every year

(Newser) - US officials on Monday approved the first long-acting drug to protect babies and toddlers against a respiratory virus that sends tens of thousands of American children to the hospital each year. RSV is a cold-like nuisance for most healthy people, but it can be life-threatening in the very young and...

First No-Prescription Birth Control Pill Is Approved

Opill will likely be available in stores early next year following FDA move

(Newser) - It's a US milestone in regard to birth control: The FDA on Thursday approved the first over-the-counter pill to prevent pregnancies, reports CNN . The medication called Opill, made by Perrigo Company, is expected to be available in stores in early 2024. No word yet on cost, though Perrigo says...

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...

FDA Makes a Big Move on Alzheimer's Treatment

Drug Leqembi, shown to slow progression, receives full approval

(Newser) - In a move with big implications for Alzheimer's treatment, the FDA on Thursday gave full approval to the first drug shown to slow the disease's progression, though modestly, reports the Washington Post . The drug, called Leqembi and marketed by Eisai and Biogen, received conditional approval back in January....

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...

Eye Drops Recall: Deaths, Blindness, Now an FDA Inspection
Eyedrops Recall:
4th Death Linked to Outbreak
updated
May 22, 2023 11:05 AM CDT

Eyedrops Recall: 4th Death Linked to Outbreak

CDC counts more than 80 people affected in 18 states by EzriCare artificial tears

(Newser) - A fourth death has been linked to an outbreak of drug-resistant bacteria blamed on eyedrops, reports USA Today . The CDC now counts 81 patients in 18 states affected by the outbreak, which prompted the recall of EzriCare artificial tears, made by Global Pharma Healthcare. The CDC also warns people to...

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...

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...

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...

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