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Regulatory & Policy

FDA actions, approvals, policy shifts and compliance: how the rules change timelines and probability.

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Archive

Report: How Employers Can Better Manage GLP-1s for AdolescentsMay 21, 2026

Report: How Employers Can Better Manage GLP-1s for Adolescents

The surge in GLP-1 drug utilization and associated costs poses challenges for employer-sponsored insurance plans that are self-insured. Strategic management approaches are needed to address the financial impact while supporting adolescent patients.

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Surgeon General Issues Advisory on Children’s Screen Time and Public HealthMay 20, 2026

Surgeon General Issues Advisory on Children’s Screen Time and Public Health

As digital device use becomes ubiquitous in childhood, concerns have risen regarding its impact on development and well-being. The Surgeon General’s advisory highlights the emerging evidence on how excessive or improper screen time can pose real harm, inviting a coordinated response to protect pediatric populations.

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FDA Report Confirms No Child Deaths Definitively Caused by COVID-19 VaccinationMay 19, 2026

FDA Report Confirms No Child Deaths Definitively Caused by COVID-19 Vaccination

Amid ongoing debates over COVID-19 vaccine safety, especially in children, an FDA report has provided evidence that counters claims of fatal adverse events linked to pediatric COVID immunizations. This detailed examination summarizes the report, assesses its implications for public health policy, and discusses the broader challenge of misinformation in vaccine discourse.

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FDA Approval Marks New Era in Hypertension Treatment with AstraZeneca’s BaxfendyMay 18, 2026

FDA Approval Marks New Era in Hypertension Treatment with AstraZeneca’s Baxfendy

AstraZeneca's recent FDA approval of Baxfendy brings forward a new class of hypertension drugs targeting aldosterone synthase. This approval not only offers hope to patients with high blood pressure but also represents AstraZeneca's strategic move amid looming patent expirations on its cardiometabolic portfolio.

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UK Advocacy Groups Challenge Pharmaceutical Trade Deal with US Amidst Legal ThreatsMay 18, 2026

UK Advocacy Groups Challenge Pharmaceutical Trade Deal with US Amidst Legal Threats

New regulations central to the UK-US pharma trade deal have sparked significant concern among advocacy groups in the UK. These groups argue that the deal contains provisions that could negatively impact public health and access to medicines, prompting threats of court action unless the UK government revokes the controversial regulations. Such developments underscore the complexities at the intersection of trade agreements and healthcare policy.

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STAT+: The hantavirus outbreak is prompting Covid flashbacks — including the conspiraciesMay 17, 2026

STAT+: The hantavirus outbreak is prompting Covid flashbacks — including the conspiracies

This article explores the parallels between the hantavirus outbreak and the Covid-19 pandemic, focusing on public perception, misinformation, and the broader implications for outbreak management and communication. It examines how the laneway of conspiracy theories re-emerged amid health crisis, echoing past challenges during the global pandemic.

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WHO Declares Ebola Outbreak an International Public Health EmergencyMay 17, 2026

WHO Declares Ebola Outbreak an International Public Health Emergency

The recent announcement by WHO underscores significant international apprehension surrounding the Ebola outbreak spreading through the Democratic Republic of the Congo and Uganda. This declaration signals an increased urgency for coordinated global response efforts to contain the disease and mitigate further spread across borders.

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Interim CDER Head Tracy Beth Høeg Departs FDA Amid Continued Leadership ChangesMay 15, 2026

Interim CDER Head Tracy Beth Høeg Departs FDA Amid Continued Leadership Changes

The FDA is experiencing significant leadership upheaval, highlighted by the recent resignations within its highest ranks. The exit of interim CDER head Tracy Beth Høeg shortly after Commissioner Makary's resignation raises questions about the agency’s internal dynamics and the potential impact on its regulatory functions. This article explores the circumstances and implications surrounding these high-profile departures at the FDA.

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Other beats

AI in Drug Discovery

Machine learning, predictive models and computational biology: how AI is changing discovery workflows and probability of success.

Biopharmaceutical Industry

Drug development, clinical trials and industry dynamics. What changes timelines, risk and competitive positioning.

Biotech Innovation

Gene therapy, CRISPR, synthetic biology and emerging platforms. Separating what is real from what is hype, and what actually translates.

Healthcare Investment

Where capital is flowing and why the tape moves, across funding rounds, M&A, IPOs and market analysis.

Medical Technology

Digital health, diagnostics and medical devices, and the signals that matter for adoption, reimbursement and outcomes.