Food and Drug Administration

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There's Been a Date Shift for FDA's Full OK on Pfizer Vax

Labor Day was the initial target. Sources now say full approval could come as soon as Monday.

(Newser) - Earlier this month, the Food and Drug Administration signaled that it hoped to offer full approval for Pfizer-BioNTech's coronavirus vaccine by Labor Day, an unofficial deadline that now looks like it's been expedited. A senior federal official tells CNN that such an FDA OK is "imminent,"...

FDA Authorizes 3rd COVID Vaccine Dose for 3% of Adults

CDC to issue recommendation on the boosters for certain immunocompromised people

(Newser) - A third COVID-19 vaccine dose has been authorized for certain immunocompromised Americans. The FDA on Thursday amended the emergency use authorizations for the Pfizer-BioNTech and Moderna vaccines to allow a third dose for "solid organ transplant recipients or those who are diagnosed with conditions that are considered to have...

FDA Speeds Up Plans to Help Immunocompromised

Agency said to be fast-tracking COVID booster shots for the most medically vulnerable

(Newser) - Conversations within the FDA, CDC, and NIH have begun regarding COVID-19 booster shots, with the Biden administration indicating plans will pick up steam early next month to get that plan going for the general population. "The agencies are engaged in a science-based, rigorous process to consider whether or when...

FDA Approval of Alzheimer's Drug to Be Reviewed

Agency chief fears damage to public confidence in process

(Newser) - The acting head of the Food and Drug Administration wants the agency's inspector general to conduct an independent review of the agency's approval of a new drug to treat Alzheimer's. The approval process, which one outside adviser had called a "sham" as he resigned, has been...

Pfizer Wants Approval for Third Shot

Company agrees effectiveness of its vaccine is fading as Delta variant surges

(Newser) - Seeing signs that the effectiveness of its vaccine is fading, Pfizer said Thursday it will ask for approval to distribute a third dose to help fight new coronavirus variants. The company plans to ask the Food and Drug Administration for emergency use authorization next month, CNN reports. Pfizer cited findings...

FDA Walks Back Broad Alzheimer's Drug Advice

After criticism, agency says label will limit candidates to those with mild symptoms

(Newser) - After being widely criticized for approving the use of a new drug to treat all Alzheimer's patients, despite only limited evidence that it works, the Food and Drug Administration has stepped back from that decision. The agency announced its new instructions Thursday that say Aduhelm is intended only for...

New Alzheimer's Drug Spurs Big Concerns, an Investigation

2 House committees launch inquiry into approval, cost of Biogen's Aduhelm

(Newser) - It was supposed to have been a "cause for celebration," but instead, it's become a "catastrophe in the making." That's Axios' recent take on Aduhelm , the costly new Alzheimer's drug that was approved by the Food and Drug Administration despite major reservations from...

Another Company to Ask FDA to Approve Alzheimer's Drug

Biogen just won approval for its treatment despite experts' dissent

(Newser) - Eli Lilly is nearly ready to take another shot at getting approval for a possible Alzheimer's drug. The drugmaker said Thursday that it plans to submit its potential treatment donanemab to the Food and Drug Administration later this year. The announcement comes a few weeks after the FDA approved...

Cost of Alzheimer's Drug Could Push Medicare to the Brink

Biogen product would nearly double program's medication budget, though it might not work

(Newser) - The Food and Drug Administration's approval of a new drug to treat Alzheimer's disease could have enormous implications not just for patients, but for Medicare—even pushing the program toward collapse. FDA approval historically has meant Medicare will cover the cost of the medication, but with Biogen's...

Alzheimer Drug 'Debacle' Continues With Yet Another Resignation

Aaron S. Kesselheim is 3rd FDA adviser to resign after agency approves Aduhelm

(Newser) - The "debacle" over an Alzheimer's drug recently approved by the Food and Drug Administration continues, or at least that's how the commotion is being described by a third adviser to the agency who's now quit over it. Mayo Clinic neurologist Dr. David Knopman and Washington University...

FDA Advisers Quit Over Alzheimer's Drug: 'Sham Process'

They're not happy the agency OK'd Biogen's Aduhelm against panel's recommendation

(Newser) - The week kicked off with controversy swirling around aducanumab, the drug being marketed by Biogen as Aduhelm to treat Alzheimer's disease. The drama continues, with two members of an advisory panel to the Food and Drug Administration stepping down over the agency's decision to OK the drug against...

FDA Approves Controversial New Alzheimer's Drug

Biogen's aducanumab receives green light, despite questions about effectiveness

(Newser) - Big news in the world of Alzheimer's: The FDA on Monday approved the first new treatment in nearly 20 years, disregarding warnings from independent advisers that the drug hasn't been shown to help slow the brain-destroying disease, per the AP . The drug aducanumab is made by Biogen and...

Biden Sets New Vaccination Goal
Biden Sets New
Vaccination Goal

Biden Sets New Vaccination Goal

President wants 70% of adults to have a dose by July 4

(Newser) - President Biden on Tuesday issued some new targets on the vaccine front: His new goal is 70% of the adult population having had at least one shot by July 4. The administration also wants to see 160 million Americans fully vaccinated by then. Despite the decline in vaccination pace, the...

FDA Reverses on Abortion Pill Access During Pandemic

As they could before Trump, women don't have to go in person for mifepristone

(Newser) - Women seeking an abortion pill will not be required to visit a doctor's office or clinic during the COVID-19 pandemic, US health officials said Tuesday. It's the latest reversal in an ongoing legal battle over the medication. The FDA announced the policy change in a letter to the...

Temperature Scanners Can Miss Infected People
Fever Scanners Might
Miss Coronavirus Cases
new study

Fever Scanners Might Miss Coronavirus Cases

Research shows devices can be unreliable, and FDA issues warning

(Newser) - People infected with the coronavirus might be sailing through checkpoints because of problems with temperature scanners. Thermal cameras and "temperature tablet" kiosks have been installed around the country since the pandemic began, in an effort to keep anyone with the virus from entering workplaces, schools, arenas and other public...

Expert Panel's Vote on Third Vaccine Is Unanimous

Johnson & Johnson version requires a single shot and can be kept at refrigerator temperatures

(Newser) - A panel of experts recommended Friday that the Food and Drug Administration approve emergency use of Johnson & Johnson's new coronavirus vaccine. After the panel's 22-0 advisory vote, authorization could be granted by the FDA over the weekend, the Washington Post reports, putting the first few million doses...

FDA Drops Ultra-Cold Storage Rule for Pfizer Vaccine

Allowing regular freezer temperatures should simplify distribution

(Newser) - The Food and Drug Administration made distribution of the Pfizer coronavirus vaccine easier on Thursday by decreeing it can be stored in regular freezer temperatures after all. The agency had required the vaccine be kept at minus 76 degrees Fahrenheit to minus 112 degrees, the Hill reports. That was a...

Baby Foods Contain Toxic Heavy Metals: Report

House panel pushes FDA to set standards

(Newser) - A House Oversight Committee report says alarming levels of toxic heavy metals—including arsenic, lead, cadmium, and mercury—have been found in major-label baby food products. The heavy metals can imperil infant neurological development in infants. The subcommittee's chairman expressed frustration with federal regulators, the Washington Post reports. "...

Pet Foods Recalled After Deaths of 28 Dogs

Tests find toxin in some Sportmix lots

(Newser) - Federal regulators are warning pet owners that some pet foods sold under the Sportmix label "may contain potentially fatal levels of aflatoxin." At least 28 dogs died after eating dog food that was found to have high levels of the toxin, NBC reports. Another eight became ill. Midwest...

Outside Experts Endorse Moderna Vaccine

FDA is on track to approve emergency use on Friday, with distribution starting in days

(Newser) - The Food and Drug Administration plans to approve a second coronavirus vaccine for emergency use on Friday, after an outside panel of experts agreed that the benefits of Moderna's product outweigh the risks. The head of the federal vaccine distribution effort plans to ship nearly 6 million doses to...

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