Tag #Fda

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cnnespanol.cnn.com

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May 22, 07:12

FDA Ban on Compounded GLP-1 Drugs Restricts Access for Thousands

The FDA's ban on compounded GLP-1 medications, effective this week, will restrict access for thousands of patients who rely on these lower-cost alternatives for weight loss and diabetes, despite concerns about potential shortages and insurance coverage challenges.

FDA Ban on Compounded GLP-1 Drugs Restricts Access for Thousands

The FDA's ban on compounded GLP-1 medications, effective this week, will restrict access for thousands of patients who rely on these lower-cost alternatives for weight loss and diabetes, despite concerns about potential shortages and insurance coverage challenges.

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What are the underlying causes of the GLP-1 drug shortage, and how do insurance policies affect patient access?

The decision connects to broader concerns about drug pricing and accessibility. Compounded GLP-1 medications offered a lower-cost option, but lacked FDA approval, raising safety concerns. The ban could exacerbate existing shortages and increase pressure on brand-name drug supplies.

abcnews.go.com

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May 22, 04:09

Multistate Salmonella Outbreak Linked to Cucumbers

A multistate salmonella outbreak, impacting 26 individuals across 15 states (9 hospitalized), is linked to cucumbers from Bedner Growers Inc., distributed by Fresh Start Produce Inc., between April 29 and May 19, 2025; the FDA and CDC are investigating.

Multistate Salmonella Outbreak Linked to Cucumbers

A multistate salmonella outbreak, impacting 26 individuals across 15 states (9 hospitalized), is linked to cucumbers from Bedner Growers Inc., distributed by Fresh Start Produce Inc., between April 29 and May 19, 2025; the FDA and CDC are investigating.

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What systemic factors contributed to this outbreak, and what measures are being taken to prevent future occurrences?

The outbreak highlights the vulnerability of food supply chains to contamination, impacting both restaurants and consumers. Bedner Growers Inc. initiated a voluntary recall after the FDA investigation, demonstrating a company response to a public health crisis. This follows a similar 2024 incident, raising questions about the company's safety protocols.

foxnews.com

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May 21, 01:11

FDA Shifts COVID-19 Vaccine Policy to Prioritize High-Risk Individuals

The FDA is shifting its annual COVID-19 vaccine approval policy to prioritize high-risk individuals (over 65 and those with increased risk factors) while demanding more robust data for low-risk individuals, aiming to rebuild public trust and align with international guidelines; this will affect vacc...

FDA Shifts COVID-19 Vaccine Policy to Prioritize High-Risk Individuals

The FDA is shifting its annual COVID-19 vaccine approval policy to prioritize high-risk individuals (over 65 and those with increased risk factors) while demanding more robust data for low-risk individuals, aiming to rebuild public trust and align with international guidelines; this will affect vacc...

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Why is the FDA shifting from a 'one-size-fits-all' approach to a risk-based approach for COVID-19 vaccines?

This policy change reflects a move away from a 'one-size-fits-all' approach, aligning U.S. guidelines with those of other high-income nations. The FDA acknowledges the public's uncertainty and divided opinions regarding repeated COVID-19 vaccine doses, aiming to rebuild trust through evidence-based decisions and transparent communication. This approach prioritizes targeted vaccination based on risk assessment.

us.cnn.com

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May 21, 16:12

FDA Ends Grace Period for Compounded GLP-1 Drugs, Raising Access Concerns

The FDA will end a grace period allowing the sale of compounded GLP-1 drugs for weight loss and diabetes, starting Thursday, impacting thousands of patients who rely on cheaper alternatives; brand-name drug shortages were declared over, leading to this decision.

FDA Ends Grace Period for Compounded GLP-1 Drugs, Raising Access Concerns

The FDA will end a grace period allowing the sale of compounded GLP-1 drugs for weight loss and diabetes, starting Thursday, impacting thousands of patients who rely on cheaper alternatives; brand-name drug shortages were declared over, leading to this decision.

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What factors contribute to the ongoing challenges in accessing GLP-1 medications, beyond the recent FDA decision?

The decision to halt compounded GLP-1 drug sales stems from the FDA's assertion that brand-name drug shortages have ended. However, concerns remain about the financial accessibility of brand-name alternatives, considering that many patients relied on compounded drugs due to lower cost. Insurance coverage complexities further complicate access, potentially jeopardizing ongoing treatment for many.

cbsnews.com

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May 21, 19:13

FDA Expands COVID-19 Vaccine Warnings for Myocarditis Risk in Young Men

The FDA is expanding warning labels on Pfizer and Moderna's COVID-19 vaccines to include a higher risk of myocarditis and pericarditis in males aged 16-25, citing a rate of 38 cases per million doses compared to 8 per million in other groups, based on a study published last year and new agency data....

FDA Expands COVID-19 Vaccine Warnings for Myocarditis Risk in Young Men

The FDA is expanding warning labels on Pfizer and Moderna's COVID-19 vaccines to include a higher risk of myocarditis and pericarditis in males aged 16-25, citing a rate of 38 cases per million doses compared to 8 per million in other groups, based on a study published last year and new agency data....

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What factors contributed to the FDA's decision to expand the warning labels on the COVID-19 vaccines?

This FDA action connects to broader concerns about vaccine safety and transparency. The increased warning for a specific demographic highlights the importance of ongoing surveillance and data analysis in vaccine safety assessments. The timing of the announcement, shortly before a Senate hearing on vaccine safety, suggests political considerations may also be at play.

mk.ru

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May 20, 10:13

Class-Action Lawsuit Alleges Popular Food Packaging Releases Harmful Microplastics

A class-action lawsuit in California accuses a popular food packaging brand used by over 200 million Americans of misleading consumers about the safety of its microwaveable containers and bags, claiming they release harmful microplastics when heated or frozen; the lawsuit cites studies showing a 50%...

Class-Action Lawsuit Alleges Popular Food Packaging Releases Harmful Microplastics

A class-action lawsuit in California accuses a popular food packaging brand used by over 200 million Americans of misleading consumers about the safety of its microwaveable containers and bags, claiming they release harmful microplastics when heated or frozen; the lawsuit cites studies showing a 50%...

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What are the immediate health implications for the 200 million Americans who use this brand's food packaging, given the allegations of microplastic release?

A popular brand of food packaging used by over 200 million Americans is facing a class-action lawsuit in California. The lawsuit alleges that the company misled consumers about the safety of its microwaveable containers and bags, claiming that they release harmful microplastics when heated or frozen. The lawsuit specifically mentions freezer bags, slider bags, and containers.

cnn.com

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May 22, 07:12

FDA Mandates Updated Covid-19 Vaccine Warning Labels

The FDA mandates updated Covid-19 vaccine warning labels for Pfizer-BioNTech and Moderna, specifying a slightly increased risk of myocarditis/pericarditis in males aged 16-25 based on health insurance claims data analysis showing 38 cases per million doses, highlighting the importance of transparenc...

FDA Mandates Updated Covid-19 Vaccine Warning Labels

The FDA mandates updated Covid-19 vaccine warning labels for Pfizer-BioNTech and Moderna, specifying a slightly increased risk of myocarditis/pericarditis in males aged 16-25 based on health insurance claims data analysis showing 38 cases per million doses, highlighting the importance of transparenc...

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How do the newly revealed risk patterns in the insurance data relate to broader concerns about vaccine safety and public trust?

This FDA action connects to broader concerns about vaccine safety transparency. While the risk remains statistically rare, the increased labeling directly responds to identified patterns in adverse events. This highlights ongoing efforts to balance vaccine benefits with thorough risk communication, addressing public anxieties and maintaining trust.

npr.org

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May 21, 10:12

FDA Prioritizes COVID-19 Vaccine Approvals For High-Risk Groups

The FDA announced a revised approach to approving COVID-19 vaccines, prioritizing high-risk groups (65+ and those with health conditions) while mandating extensive new studies for others, potentially limiting access for healthy younger adults due to insurance changes.

FDA Prioritizes COVID-19 Vaccine Approvals For High-Risk Groups

The FDA announced a revised approach to approving COVID-19 vaccines, prioritizing high-risk groups (65+ and those with health conditions) while mandating extensive new studies for others, potentially limiting access for healthy younger adults due to insurance changes.

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What is the FDA's new approach to COVID-19 vaccine approval, and what are its immediate consequences for vaccine accessibility?

The FDA will prioritize COVID-19 vaccine approval for high-risk groups (65+ and those with health issues), requiring new large-scale studies to prove safety and effectiveness for others. This change aims to restore public trust and align with international practices, potentially impacting vaccine access for low-risk individuals.

abcnews.go.com

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May 21, 07:11

COVID-19 Vaccine Approval Limited to High-Risk Groups

The Trump administration announced it will limit approval of seasonal COVID-19 shots to seniors and high-risk individuals, pending more data, causing concerns about access for those who want a fall booster, reversing the previous policy recommending annual shots for everyone over six months.

COVID-19 Vaccine Approval Limited to High-Risk Groups

The Trump administration announced it will limit approval of seasonal COVID-19 shots to seniors and high-risk individuals, pending more data, causing concerns about access for those who want a fall booster, reversing the previous policy recommending annual shots for everyone over six months.

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What are the immediate implications of the Trump administration's decision to limit COVID-19 vaccine access to seniors and high-risk individuals?

The Trump administration announced that approval for seasonal COVID-19 shots will be limited to seniors and high-risk individuals, pending further data. This decision raises concerns about vaccine access for those wanting a fall booster, marking a departure from the previous policy of recommending annual shots for all Americans aged six months and older. More than 100 million Americans still qualify for a booster under the new guidelines.

kathimerini.gr

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May 21, 19:12

FDA-Approved Blood Test Revolutionizes Alzheimer's Diagnosis in Greece

The FDA-approved Lumipulse blood test, now available at the Ionian University's laboratory in Greece, offers a highly accurate, non-invasive method for diagnosing Alzheimer's disease, impacting 35 million individuals globally and potentially accelerating treatment.

FDA-Approved Blood Test Revolutionizes Alzheimer's Diagnosis in Greece

The FDA-approved Lumipulse blood test, now available at the Ionian University's laboratory in Greece, offers a highly accurate, non-invasive method for diagnosing Alzheimer's disease, impacting 35 million individuals globally and potentially accelerating treatment.

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What is the significance of the FDA's approval of the Lumipulse blood test for Alzheimer's diagnosis?

A new blood test for Alzheimer's, developed by Fujirebio Diagnostics and approved by the FDA, can now be administered at the Ionian University's BioInformatics and Human Electrophysiology Laboratory. This test, Lumipulse, measures the ratio of two proteins in the blood to assess the likelihood of amyloid plaque buildup in the brain, offering a faster, less invasive alternative to previous diagnostic methods.

abcnews.go.com

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May 21, 19:13

FDA Limits Future COVID-19 Vaccine Access to Older Adults and Those with Underlying Conditions

The FDA announced it will restrict future COVID-19 vaccine access to people over 65 or with underlying health conditions, citing lack of benefit for healthy individuals and the cost of large trials; this affects an estimated 230 million Americans, aligning with policies in other countries.

FDA Limits Future COVID-19 Vaccine Access to Older Adults and Those with Underlying Conditions

The FDA announced it will restrict future COVID-19 vaccine access to people over 65 or with underlying health conditions, citing lack of benefit for healthy individuals and the cost of large trials; this affects an estimated 230 million Americans, aligning with policies in other countries.

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What are the main arguments for and against the FDA's policy change regarding COVID-19 vaccine access for healthy younger adults?

This policy shift reflects a change in the approach to COVID-19 vaccination, moving away from a universal booster program. The FDA's justification cites the lack of substantial benefit for healthy individuals and the high cost of large-scale trials for annual updates. This aligns with similar restrictions in the U.K., Canada, and Australia.

abcnews.go.com

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May 17, 01:09

FDA Clears First Blood Test for Alzheimer's Diagnosis

The FDA approved Fujirebio Diagnostics' blood test for Alzheimer's diagnosis in those over 55 with symptoms; the test measures plasma proteins pTau217 and β-amyloid 1-42, showing 91% accuracy for positive and 97% for negative results in a study of almost 500 patients, offering a less invasive diagno...

FDA Clears First Blood Test for Alzheimer's Diagnosis

The FDA approved Fujirebio Diagnostics' blood test for Alzheimer's diagnosis in those over 55 with symptoms; the test measures plasma proteins pTau217 and β-amyloid 1-42, showing 91% accuracy for positive and 97% for negative results in a study of almost 500 patients, offering a less invasive diagno...

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What is the immediate impact of the FDA's approval of the first blood test for Alzheimer's disease?

The FDA cleared Fujirebio Diagnostics' blood test for Alzheimer's disease in individuals over 55 exhibiting symptoms. The test measures plasma proteins pTau217 and β-amyloid 1-42, correlating their ratio to amyloid plaques indicative of Alzheimer's. High accuracy rates (91% positive, 97% negative) were observed in a clinical study of nearly 500 patients.

Showing 73 to 84 of 215 results