The U.S. Food and Drug Administration (FDA) on Tuesday classified the recent recall of some of Philips’ ventilators as Class 1, or the most serious type of recall, saying the use of these devices may cause serious injuries or death. This is the second Class 1 recall initiated by the company this year. In June,…
FDA Classifies Philips Ventilator Recall Due to Low Oxygen Risk as Most Serious
Live Q&A: Vaccine Mandates Declared Legal by DOJ; Florida Lawmaker Calls for Election Audit
The Department of Justice (DOJ) has declared that it’s legal for public agencies and private businesses to require vaccinations for COVID-19, under the FDA’s emergency use authorization. And in other news, a lawmaker in Florida is now calling for an election audit, similar to what’s now underway in Arizona. In this live Q&A with Crossroads…
FDA Classifies Philips Ventilator Recall as Most Serious
The Food and Drug Administration (FDA) on Thursday classified the recall of Philips’ breathing devices and ventilators as Class 1, or the most serious type of recall, saying the use of these devices may cause serious injuries or death. The agency said there have been 83 complaints regarding the products used to provide breathing assistance,…
US Review of Biogen Alzheimer’s Drug Could Have Been Handled Differently: FDA Chief
The U.S. Food and Drug Administration could potentially have done more to avoid the current controversies around its accelerated approval of Biogen’s Alzheimer’s drug, Aduhelm, FDA acting Commissioner Janet Woodcock said during a Wednesday summit hosted by Stat. The FDA last week called for an independent federal probe into its representatives’ interactions with Biogen ahead…
You’re Knocking on My Door for What? | Real Talk
When I read the news about the Biden administration pushing a door-to-door COVID vaccination team, I didn’t think much of it. It was more humorous than serious. It was yet another gaffe, I thought. After watching Health and Human Services Chairman Xavier Beccera on CNN last week claim it was the government’s right to know…
FDA Head Calls for Probe Into Alzheimer’s Drug Review
WASHINGTON—The acting head of the Food and Drug Administration on Friday called for a government investigation into highly unusual contacts between her agency’s drug reviewers and the maker of a controversial new Alzheimer’s drug. Dr. Janet Woodcock announced the extraordinary step via Twitter. It’s the latest fallout over last month’s approval of Aduhelm, an expensive…
Pfizer to Ask FDA to Authorize Booster Dose of COVID Vaccine as Delta Variant Spreads
NEW YORK—Pfizer Inc plans to ask U.S. regulators to authorize a booster dose of its COVID-19 vaccine within the next month, the drugmaker’s top scientist said on Thursday, based on evidence of greater risk of reinfection six months after inoculation and the spread of the highly contagious Delta variant. Pfizer Chief Scientific Officer Mikael Dolsten…
Provention Bio Shares Tumble as US FDA Declines to Approve Diabetes Drug
The U.S. health regulator on Tuesday declined to approve Provention Bio Inc’s experimental diabetes drug, citing insufficient data, sending the company’s shares down about 28 percent. The Food and Drug Administration (FDA) said a study in healthy volunteers failed to show that the drug is comparable to its older version used in the clinical trials….
FDA Adds Warning About Heart Inflammation to COVID-19 mRNA Vaccines
The U.S. Food and Drug Administration (FDA) added a warning about the risk of developing a rare heart inflammation for the Moderna and Pfizer COVID-19 vaccines. The FDA earlier this month announced that it would add the warning after the Centers for Disease Control and Prevention (CDC) reported more cases of heart inflammation—either myocarditis or…
4,115 Vaccinated People Have Died, Been Hospitalized With COVID-19 ‘Breakthrough’ Infections: CDC
The U.S. Centers for Disease Control and Prevention (CDC) said that more than 4,000 people have been hospitalized or died from COVID-19 “breakthrough” cases. The agency, in an update late last week, said that 4,115 people have been hospitalized or have died from COVID-19 despite having been fully vaccinated. The total number of individuals who…
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