FDA

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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...

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 Solves Problem of Expiring Vaccines

Doses will be considered good for 4.5 months now, up from 3

(Newser) - State health officials have been nervous about hundreds of thousands of doses of Johnson & Johnson coronavirus vaccine scheduled to expire in June. It's not an issue anymore. The Food and Drug Administration told the company Thursday to consider the shelf life of the product to be 4½ months,...

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...

FDA Issues Advice on Eating Cicadas

People with seafood allergies should avoid eating the insects

(Newser) - Trillions of Brood X cicadas have emerged in eastern states after 17 years underground—and while the insects are being praised as a tasty low-fat food source, the Food and Drug Administration has sounded a note of caution. "Yep! We have to say it! Don't eat cicadas if...

Psychedelic Drug Shows Great Promise for PTSD Sufferers

Therapy assisted by MDMA (aka ecstasy) could be approved by 2023

(Newser) - Ecstasy appears on track to become an FDA-approved prescription treatment if the results of the first Phase 3 trial on psychedelic-assisted therapy are any indication. As the New York Times reports, 67% of PTSD patients who were given a dose of the drug during therapy no longer qualified for a...

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...

Pfizer Asks OK for Younger Recipients

FDA approval probably is a few weeks away

(Newser) - Pfizer asked the Food and Drug Administration on Friday to add recipients ages 12 to 15 to the emergency use authorization for its coronavirus vaccine. At the moment, Pfizer has permission to distribute the vaccine for anyone 16 or older. The company said last week that its trials showed its...

2 Vaccines Collided at Plant Flagged by FDA

15M doses of Johnson & Johnson's vaccine were ruined as a result

(Newser) - The plant that lost up to 15 million doses of Johnson & Johnson's one-dose vaccine had something of a history of prior FDA violations. That's according to the AP and Washington Post , which obtained a copy of the FDA investigator's report from a year ago. It found...

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...

FDA Backs Adding Vaccine to Every Moderna Vial

Production line changes will take a couple of months

(Newser) - Moderna and the Food and Drug Administration have agreed on a way to get more coronavirus vaccine to its destination, and it sounds simple enough: Put more in each vial. Filling the vials closer to the brim will put 40% more in each, the New York Times reports—14 doses...

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...

FDA Has French Dressing, Cherry Pie in Crosshairs

The agency wants to deregulate some American pantry staples

(Newser) - The Food and Drug Administration has made the stripping away of rules that have governed the content and quality of certain foodstuffs a priority under the Trump administration, and some odd targets appear to be at the top of the list as Washington prepares to transition to a President Biden....

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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