Biopharmaceutical company InflaRx NV’s monoclonal antibody has been granted emergency use authorization (EUA) by the Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adults. The FDA said on April 4 that it had issued the EUA for the use of Gohibic, a brand name of vilobelimab, a monoclonal anti-human complement factor C5a antibody, to be injected into hospitalized…
FDA Grants Emergency Use Authorization for InflaRx COVID-19 Drug in Critically Ill Patients
FDA Announces Recall of Drug of Possible Contamination That Can Cause ‘Life Threatening Infections’
Camber Pharmaceuticals said it recalled some of its pneumonia medicine after it discovered the drug may be contaminated with the Bacillus cereus bacteria, according to a U.S. Food and Drug Administration (FDA) announcement. The voluntary recall impacts one lot of Atovaquone Oral Suspension, USP in either 750-milligram or 5-milliliter doses to the consumer level due to possible…
FDA Approves Over-the-Counter Narcan—Here’s What It Means
The U.S. Food and Drug Administration on Wednesday approved selling naloxone without a prescription, setting the overdose-reversing drug on course to become the first opioid treatment drug to be sold over the counter. It’s a move that some advocates have long sought as a way to improve access to a life-saving drug, though the exact…
FDA Seeks to Allow Salt Substitutes in Everyday Foods
The Food and Drug Administration (FDA) on Friday said it was proposing a rule to allow the use of salt substitutes in everyday foods including cheese, frozen peas, and canned tuna, in a bid to cut Americans’ salt consumption. The FDA had in 2021 set a new voluntary goal for manufacturers and chain restaurants to…
Beware of Toxic Spices: Heavy Metals Found in Major Brand Names
March 25, 2023
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Despite four lawsuits over the last two years over significant levels of toxic heavy metals in big brand names of herbs and spices found in a 2021 consumer report, big box stores continue to carry the listed brands and the U.S. Food and Drug Administration (FDA) has not yet set stricter limits on heavy metals…
FDA Notice: Common Stroke Medication Recalled Over Cancer-Causing Chemical
The U.S. Food and Drug Administration (FDA) announced the recall of a commonly used stroke medication after the company discovered the presence of a potentially cancer-causing impurity. In an FDA-issued recall notice on March 22, Ascend Laboratories LLC said it is recalling Dabigatran Etcxilate Capsules at the consumer level after nitrosamine, a carcinogenic substance, was found about the…
House Oversight Committee Probes FDA’s Response to Baby Formula Shortage
March 21, 2023
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Republicans on the House Oversight and Accountability Committee are pressing the U.S. Food and Drug Administration (FDA) for information about the agency’s response to the nationwide infant formula shortage. In a March 21 letter (pdf) to FDA Commissioner Robert Califf, Committee Chairman James Comer (R-Ky.) and Rep. Lisa McClain (R-Mich.), chair of the Subcommittee on…
Nationwide Recall Issued for Frozen Strawberries at Major Retailers Following Hepatitis A Outbreak
A nationwide recall was issued by the U.S. Food and Drug Administration (FDA) on March 17. The recall affects frozen strawberries that are potentially linked to a Hepatitis A outbreak and have been sold across various retailers. According to the Centers for Diseases Control and Prevention (CDC), a possible link was established after five cases…
Texas Judge Considering Fate of Abortion Pill; Ruling Expected ‘As Soon As Possible’
A federal judge in Texas will decide whether the abortion pill, mifepristone, should be restricted or taken off the market. U.S. District Judge Matthew Kacsmaryk, who heard arguments from both sides during a hearing in Amarillo on Wednesday, told lawyers he would issue a ruling “as soon as possible,” the Associated Press reported. The hearing…
LIVE NOW: FDA Advisers Meet to Discuss Pfizer’s COVID-19 Pill
March 16, 2023
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The Antimicrobial Drugs Advisory Committee, which advises the U.S. Food and Drug Administration, meets at 9 a.m. ET on March 16 to discuss a new application for Pfizer’s Paxlovid pill for oral use. The pill treats mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID 19, including hospitalization or death….
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