FDA

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Booster Shots Are Expected to Start Going in Arms Today

CDC, Walensky gave final approval Thursday night

(Newser) - Update: An advisory panel unanimously recommended to the Centers for Disease Control and Prevention on Thursday that coronavirus vaccine booster shots be approved. Tens of millions of people would be eligible for the doses, which the FDA backed the day before, the Washington Post reports. (There's an explainer on...

FDA to Study Possible Moderna Side Effect

Decision will delay approval for 12- to 17-year-olds

(Newser) - With several European nations rethinking their endorsements of giving the Moderna vaccine to young people, the FDA will study a potential side effect longer before deciding on approval. The issue is myocarditis, a rare inflammatory heart condition, the Wall Street Journal reports. Finland, Sweden, Denmark, and Norway have called for...

FDA Panel Endorses J&amp;J Booster Shot
FDA Panel Endorses
J&J Booster Shot
Oct 15, 2021 1:42 PM CDT

FDA Panel Endorses J&J Booster Shot

Advisers set no timeline but says shot should come at least 2 months after the first one

(Newser) - A panel of US health advisers endorsed booster doses of Johnson & Johnson's single-shot COVID-19 vaccine Friday, saying they should be offered at least two months after immunization. J&J has asked the Food and Drug Administration for flexibility with its booster, the AP reports, arguing that the extra...

FDA Report Is Inconclusive on Johnson & Johnson Booster

Outside advisers are meeting this week to consider approval and interval

(Newser) - It's not clear yet whether people who received the one-shot Johnson & Johnson coronavirus vaccine will be cleared to get a booster shot or will be told to switch brands. A Food and Drug Administration staff report released Wednesday said that there's evidence the J&J booster strengthened...

FDA Issues New Guidelines on Salt
FDA Issues New
Guidelines on Salt
Oct 13, 2021 9:35 AM CDT

FDA Issues New Guidelines on Salt

The target is lower, but not yet at the recommended level

(Newser) - Food companies are coming under renewed pressure to use less salt after US regulators spelled out long-awaited guidelines aimed at reducing sodium levels in dozens of foods, from chain restaurant meals to chips, cereal, and baby food. The voluntary goals finalized Wednesday for 163 foods are intended to help lower...

A Big First for FDA on E-Cigarettes
A Big First for FDA
on E-Cigarettes
Oct 13, 2021 2:19 AM CDT

A Big First for FDA on E-Cigarettes

Agency authorizes one to stay on the market

(Newser) - For the first time, the Food and Drug Administration on Tuesday authorized an electronic cigarette, saying the vaping device from RJ Reynolds can help smokers cut back on conventional cigarettes. E-cigarettes have been sold in the US for more than a decade with minimal government oversight or research. Facing a...

Pfizer Asks FDA to Authorize COVID Vaccine for Young Kids

Decision expected between Halloween and Thanksgiving

(Newser) - Pfizer and BioNTech formally requested that the FDA authorize emergency use of a coronavirus vaccine for more than 28 million US children aged 5 to 11 on Thursday, keeping in line with a plan to have the doses available by Thanksgiving . The FDA will now gather its vaccines advisory committee...

FDA Adds Its Approval to Booster Shots for Seniors

The third Pfizer dose ideally would be given six months after the second one

(Newser) - Update: Coronavirus booster shots for people 65 and older and adults otherwise vulnerable to severe illness received the Food and Drug Administration's approval on Wednesday. The agency decided that anyone in a high-risk situation, possibly because of their job, also should be able to get a Pfizer booster, the...

New Paper in Lancet: Most Don't Need Boosters

International review says they're not necessary for general population

(Newser) - A new international review of COVID cases reaches a clear recommendation: Hold off on booster shots for the general population. The new paper in the Lancet medical journal is authored by researchers from around the world, including two outgoing FDA scientists, reports the New York Times . They found no evidence...

Doctors, Pharmacists: Everyone Stop Using Ivermectin Now

AMA wants the prescriptions to stop

(Newser) - The American Medical Association has something to say about people taking ivermectin . And what they have to say, essentially, is knock it off, you’re going to get hurt. Ivermectin can be prescribed for humans for some problems—problems that have nothing to do with COVID. The CDC and FDA...

FDA Is Losing 2 of Its Vaccine Leaders

Head of the Office of Vaccines Research and Review and her deputy say they're out

(Newser) - Job openings have been at record levels this summer. Add two more openings to the tally. Two high-profile FDA vaccine regulators will depart the agency this fall, and the New York Times gives two points of context: One, that their exit could throw a wrench into the process of deciding...

Positive COVID Test Lacks One Key Element

As of now, people can't be told which variant they have

(Newser) - When someone learns they've tested positive for COVID, they might also discover that the news is surprisingly incomplete. As Insider reports, patients almost certainly will not learn which variant of the virus caught up with them. It's not because the lab can't figure it out—it's...

Pfizer Vaccine Will Now Be Marketed Under a New Name

After winning full FDA approval, company can now sell it as Comirnaty

(Newser) - It's a big development on the COVID vaccine front: The FDA on Monday gave full approval to the Pfizer shots, reports the AP . The vaccine had previously been granted an emergency-use waiver, and winning full approval—it's the first vaccine to do so—could have wide-ranging implications.
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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,"...

Experts Wary as Date Rape Drug Wins New Approval

GHB will be used for a rare sleep disroder

(Newser) - Imagine how cranky and tired you'd feel after a bad night's sleep. Now imagine that's your daily reality. For the estimated 37,000 Americans diagnosed with idiopathic hypersomnia , who never feel fully rested even after a long night's sleep, it is, per Reuters . But according to...

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: Drugstores Can Swap Out Name-Brand, Costlier Insulin

Change will make biosimilars easier to obtain

(Newser) - US regulators took action Wednesday that will make it easier to get a cheaper, near-copy of a brand-name insulin at the drugstore. Doctors now have to specifically prescribe what's called a biosimilar or OK substituting it for a more expensive brand-name insulin. Wednesday's move by the Food and...

Report: FDA to Issue New Warning on J&amp;J Vaccine
FDA Issues
New Warning
on J&J Vaccine
UPDATED
Jul 12, 2021 3:11 PM CDT

FDA Issues New Warning on J&J Vaccine

CDC says it has been linked to around 100 cases of Guillain-Barre syndrome

(Newser) - Another setback for the Johnson & Johnson COVID vaccine: The FDA has added a new warning to on the one-shot vaccine after reports of a rare side effect. The CDC says there have been around 100 reports of people contracting Guillain-Barre syndrome after receiving the J&J vaccine. Most of...

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...

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