FDA

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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...

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...

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