The U.S. Food and Drug Administration on Sept. 8 issued a safety alert about reports of cancers found in the capsule or scar tissue around breast implants. The agency stated that it had received 10 reports about squamous cell carcinoma (SCC) and 12 reports about various lymphomas related to breast implants as of Sept. 1 this year. SCC…
Cancers Reported in Scar Tissue Around Breast Implants: FDA Safety Alert
FDA Panel Now Recommending New ALS Drug After Earlier Rejection
A panel of external advisers to the U.S. Food and Drug Administration (FDA) voted on Sept. 7 to recommend a drug from Amylyx Pharmaceuticals to treat amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease or motor neuron disease. ALS is a progressive and fatal disease that has no known cure. It is a neurodegenerative disease, destroying…
Beef Jerky, Smoked Salmon Recalled in Multiple States Over Listeria Concerns
A Tennessee-based company has issued a recall for nearly 500 pounds of beef jerky products due to possible contamination of listeria, according to officials. The Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced in a Sept. 6 notice that the ready-to-eat beef jerky items were produced on Aug. 25 by the establishment Magnolia Provision and…
FDA Defends Approval of New Boosters Without Human Trials
The leadership of the U.S. Food and Drug Administration is defending its approvals of new booster vaccines for COVID-19 without completed human trials. “This is a type of vaccine that has now been given to billions of people and we have a good understanding of how it works, so it’s not like something just coming…
FDA Authorizes Updated COVID-19 Boosters Despite Lack of Clinical Data
U.S. drug regulators on Aug. 31 authorized COVID-19 vaccine booster shots despite no clinical trial data being available for the updated formulations. The U.S. Food and Drug Administration (FDA) granted emergency use authorization to Moderna and Pfizer for their updated boosters. The original vaccines were based on components of the Wuhan strain of the virus…
How Effective Is Your Cancer Medication? The Industry Might Not Even Know
August 27, 2022
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Cancer is the second leading cause of death in the United States, right on the heels of heart disease. In developed countries, the general consensus is that if you do not die of heart disease, then the next likely event is cancer. In fact, most health experts expect that everyone will eventually develop, and likely…
Trump White House Pressured FDA to Reauthorize Hydroxychloroquine: Congressional Report
White House officials during the Trump administration pressured U.S. regulators to reauthorize a COVID-19 treatment and not impose certain guidance regarding emergency authorization requirements for COVID-19 vaccines, according to emails published by a House of Representatives panel on Aug. 24. Officials sent a blitz of messages in 2020 to Dr. Stephen Hahn, the director of the…
The Declining Standards of FDA Drug Approvals
Commentary The U.S. Food and Drug Administration (FDA) has a legal obligation to protect the public and ensure that the benefits of medicines outweigh the harms before being marketed to people. But the agency’s increasing reliance on pharmaceutical industry money has seen the FDA’s evidentiary standards for drug approvals significantly decline. The Need for Speed Since the enactment of…
FDA Asks Pfizer to Test Second Paxlovid Course in Patients With COVID-19 Rebound
The Food and Drug Administration (FDA) has asked Pfizer Inc. to test the effects of an additional course of its antiviral Paxlovid among people who experience a rebound in COVID-19 after treatment, the regulator said on Friday. The drugmaker must produce the initial results of a randomized controlled trial of a second course of the…
FDA Finally Approved an Alzheimer’s Drug—But Everything Surrounding It Is Controversial
August 20, 2022
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Analysis Aduhelm is the brand name under which the Alzheimer’s drug Aducanumab is marketed. It is developed by the U.S. company Biogen. The drug is to be administered as an intra-venous infusion every four weeks. The Food and Drug Administration (FDA) approved Aducanumab in June 2021, making it the first Alzheimer’s disease medication approved by the…
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