FDA

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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...

CDC Panel Backs Booster for Ages 5-11
CDC: Children
5-11 Should
Get a Booster
updated
May 19, 2022 6:55 PM CDT

CDC: Children 5-11 Should Get a Booster

Rise in coronavirus cases prompts advisers' decision

(Newser) - Update: This file has been updated throughout with the CDC's decision. Children ages 5 to 11 should get a booster dose of Pfizer's COVID-19 vaccine, the Centers for Disease Control announced Thursday. An advisory panel had made the recommendation earlier in the day. The move opens a third...

The Dental Dam Finally Has Some Competition

The FDA has OKed underwear to protect against STIs during oral sex

(Newser) - "Oral sex is not totally risk-free," Dr. Jeanne Marrazzo, an infectious diseases expert with the University of Alabama at Birmingham tells the New York Times , but a newly FDA-authorized pair of underwear—vanilla scented, no less—has the potential to make it safer. STIs such as herpes, gonorrhea,...

FDA Clears Way to Increase Formula Imports
Formula Plant
to Go Back Online
May 16, 2022 6:55 PM CDT

Formula Plant to Go Back Online

FDA clears way to increase imports, as well

(Newser) - Federal officials on Monday reached an agreement to allow baby formula maker Abbott to restart its largest domestic factory, though it will be two months or more before any new products ship from the site to alleviate the national shortage facing parents. Under the agreement, Abbott must work with outside...

FDA Limits Authorized Use of Johnson & Johnson Vaccine

If they can, adults should get Moderna or Pfizer coronavirus shots, agency says

(Newser) - Referring to new data on blood clots, the Food and Drug Administration announced limits Thursday on who should and should not be administered Johnson & Johnson's coronavirus vaccine. Only adults unable to receive other vaccines instead, either because the products are inaccessible or they're not clinically appropriate, are...

Feds Are Preparing Plan to Ban Menthol Cigarettes
FDA Makes Big Move
to Curb Smoking
UPDATED
Apr 28, 2022 11:05 AM CDT

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...

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