Food and Drug Administration

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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...

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,...

FDA Deregulates This Salad Topping After 70 Years

Agency is revoking 'standard of identity' for French dressing, opening up ingredient possibilities

(Newser) - For nearly a quarter century, a trade group representing mayo, condiment, and salad dressing makers has been trying to get the Food and Drug Administration to back off a rule that holds one dressing in particular to what critics have said are overly strict standards. Now, it's "liberation"...

FDA: Fine to Get Booster After Just 5 Months

It also now recommends boosters for kids 12 to 15

(Newser) - The US is expanding COVID-19 boosters as it confronts the omicron surge, with the FDA allowing extra Pfizer shots for children as young as 12. Boosters already are recommended for everyone 16 and older, and federal regulators on Monday decided they're also warranted for 12- to 15-year-olds once enough...

With New Variant Comes Potential New Testing Issue

FDA warns that rapid antigen tests may not pick up on omicron that well

(Newser) - Not all news regarding the latest COVID-19 variant is gloomy, with very early signs pointing to less severe illness overall—meaning fewer hospitalizations and deaths—with omicron. When it comes to testing, however, the latest development doesn't bode well, per a warning issued by the Food and Drug Administration...

FDA Drops Restriction on Abortion Pills

Decision will allow medication to be mailed, though some states are trying to block that

(Newser) - As political efforts to further restrict access to abortion reach across the nation—and to the US Supreme Court—the FDA has removed a barrier to obtaining abortion pills. The agency on Thursday made permanent a temporary lifting of a requirement that women pick up the medication to terminate early-stage...

FDA Approves Boosters for Some Teens

Specifically, those aged 16 and 17; CDC decision is pending

(Newser) - The US is expanding COVID-19 boosters, ruling that 16- and 17-year-olds can get a third dose of Pfizer’s vaccine, per the AP . The US and many other nations already were urging adults to get booster shots to pump up immunity that can wane months after vaccination, calls that intensified...

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