FDA
The latest on the Food and Drug Administration (or FDA). Founded in 1906, the federal agency operates under the Department of Health and Human Services. Headquartered in White Oak, Maryland, the agency is responsible for the public health in regards to food and drug safety.
CDC Declines to Change Definition of 'Fully Vaccinated' Amid Third Dose
"I think we need to have more experience with our third shot...before we change that definition," said CDC Director Rochelle Walensky.
CDC's Walensky Says She Did Not Overrule Committee on Booster Shots
"As CDC director, it's my job to recognize where actions can have the greatest impact," Rochelle Walesnky said of her decision on COVID-19 booster shots.
Who Is Eligible for a Pfizer COVID-19 Booster Shot?
The FDA has approved booster shots for certain vulnerable Americans, and after a CDC vote, they could begin immediately.
COVID-19 Live Updates: California Ready For COVID Vaccine Boosters
Booster jabs for American seniors and the most vulnerable have been authorized by the FDA after months of heated debate. Follow Newsweek's liveblog for all the latest.
Fauci Confronted Over Seeming to Change Tune on Booster Shots
The National Institute of Allergy and Infectious Diseases director emphasized that the situation is still evolving as new data rolls in.
NIH Chief Supports Putting Teachers in High-Risk Category to Get Boosters
Dr. Francis Collins' statements come just days after an FDA advisory committee declined a request from Pfizer to add a third booster shot to its two-dose regimen for those aged 16 and older.
COVID Booster Shots: What's Next as FDA Panel Votes Against Pfizer Approval
The FDA advisory committee may still vote to approve the third shot for elderly populations, but the announcement is a huge setback for the Biden administration.
Pfizer Says COVID Booster Gives Antibodies in Threefold, May Handle Delta
The FDA on Wednesday posted much of the evidence from Pfizer on booster shots to be considered by its advisory panel on Friday.
When Will COVID Booster Shots Be Available? Timeline for FDA, CDC Approval
Pfizer recently submitted data in its FDA application for the booster, saying it demonstrates proof that a third shot would be safe and necessary for Americans.
Fauci Breaks With FDA Vaccine Regulators on COVID Vaccine Boosters
Fauci agreed that wealthy nations need to help vaccinate the global population but said that it can be done while booster shots are being administered.
Child COVID Cases Surge to 500k in 2 Weeks as Pfizer Awaits Vaccine Data
"Children are not small adults—and issues that may be addressed in pediatric vaccine trials can include whether there is a need for different doses or different strength formulations of vaccines already used for adults," said the FDA in a statement.
Top FDA Vaccine Regulators Warn About Impact of COVID Booster Side Effects
International scientists cautioned that "significant" adverse reactions to booster shots could make people more hesitant about getting the COVID-19 vaccine.
Plasma Therapy, Given Emergency Approval by FDA, Harmed COVID Patients
A study concluded there were more negative outcomes, including intubation and death, among those receiving convalescent plasma therapy than those receiving standard COVID-19 care.
Nasal Spray Company Prods CDC, FDA to Accept Its Claims to Help Treat COVID
The CDC has rejected Xlear's requests, saying one of the studies the company offered "presents no hard evidence ...in terms of viral load reduction."
FDA Rejects 950K Applications for Flavored e-Cigs, Delays Decision on Juul
The agency said applications for other flavored products were rejected mainly due to their appeal to underage teens, but it needed more time to consider Juul.
FDA Kicks Multiple Vape Companies Out of U.S. Market, JUUL Could Follow
The vape companies, which filed applications for 6.5 million different vaping products, have been asked by the FDA to prove their products are indeed less harmful.
Moderna Booster Awaiting Approval Likely to Miss Biden's Sept. 20 Target
Approval for the Pfizer vaccine is expected before Sept. 20, but the Moderna vaccine could be delayed until October and Johnson & Johnson even longer.
Mom Defends Ivermectin in Bizarre School Board Rant Blaming Bill Gates
The Florida woman blamed "hospital protocols" preventing the use of the drug for the death rates cited by "pro maskers."
FDA Approval Did Little to Boost U.S. Vaccinations, Experts Explain Why
While there's been a slight uptick in U.S. vaccinations, the increase has not been nearly as high as some federal officials estimated.
Patients Overdosing on Ivermectin Are Clogging Oklahoma ERs: Doctor
An emergency room physician said gunshot victims are having trouble getting ER beds due to an overflow of people sick from taking ivermectin to fight COVID-19.
What Ivermectin Is Used for and Why People Are Taking the Drug for COVID-19
Federal regulators warn ivermectin can be dangerous in large doses.
Scientists Question Joe Biden's Push for COVID Vaccine Booster Shots
Medical experts have suggested that getting people fully vaccinated is a bigger priority as the evidence is unclear as to whether third shots are needed.
Man Allegedly Sold Bleach Chemical as Cure for COVID, Cancer and Autism
The man reportedly said he also posted videos on how to make the fake miracle cure.
Disagreement Over Booster Shots Prompt Senior FDA Directors to Step Down
The duo decided upon their exit after the White House moved to start administering COVID-19 booster shots by the week of September 20, despite not having FDA approval.
Doctor Claims He Used Ivermectin on Thousands of COVID Patients
The FDA has stated the drug should not be used for treatment of coronavirus.
Biden Asks Businesses to Mandate Vaccine After Pfizer Gets FDA Approval
"It only makes sense to require a vaccine to stop the spread of COVID-19," President Joe Biden said at a Monday press conference.
Marjorie Taylor Greene Accuses Biden of Rushing Pfizer Vaccine Approval
Greene offered no basis for her belief, but said she's "not the only one" saying Biden influenced the process to help his administration.
Senators Question FDA About Working With Firm That Helped Sell Opioids
McKinsey and Co. agreed to pay nearly $600 million to almost every state and five U.S. territories over its involvement with drug makers in the sale of opioids.
Pfizer Vaccine FDA Approval Strikes Huge Blow to Mandate Resistance
Full federal approval of Pfizer's COVID-19 vaccine will likely open the door for a host of public and private organizations to introduce vaccine requirements.
Pfizer COVID Vaccine Updates: FDA Holds Briefing on Full Approval of Shot
"The moment you've been waiting for is here. It's time for you to go get your vaccination, and get it today," President Joe Biden said of Pfizer's FDA approval during an address Monday.
