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09-10-2026  HHS Announces Senior Leadership Appointments at FDA

The U.S. Department of Health & Human Services has announced new senior leadership selections at the Food and Drug Administra...
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08-10-2026  World Patient Safety Day 2026: Promoting Safe Care for Noncommunicable Diseases

On September 9, 2026, the WHO held a global webinar focused on safe care for noncommunicable diseases in alignment with World...
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07-10-2026  FDA Approval of Fayuvi for Pediatric Sanfilippo Syndrome Type A

The FDA has authorized Fayuvi, the first gene therapy for treating pediatric patients with Sanfilippo syndrome type A. This a...
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06-10-2026  FDA Approval of Belzutifan with Lenvatinib for Advanced Renal Cell Carcinoma

<p>On September 24, 2026, the U.S. Food and Drug Administration (FDA) approved the use of belzutifan in combination with lenv...
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05-10-2026  FDA Grants Accelerated Approval to Sevabertinib for HER2-Mutant NSCLC

<p>On September 9, 2026, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sevabertinib, marketed a...
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04-10-2026  FDA Approves Camzyos for Pediatric Patients with Rare Cardiomyopathy

The FDA has granted approval to Camzyos (mavacamten) to enhance functional capacity and symptom management in children with a...
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03-10-2026  FDA Grants Accelerated Approval to Etcamah for ESR1-Mutated HR+/HER2- Metastatic Breast Cancer

<p>On September 4, 2026, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Etcamah (camizestrant) i...
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02-10-2026  World Patient Safety Day 2026 Observance

On September 17, 2026, the World Health Organization observed World Patient Safety Day, focusing on patient safety as a key c...
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01-10-2026  WHO Issues New Guidance on Heat-Related Illness Prevention at Mass Gatherings

<p>The World Health Organization (WHO) has published new technical guidance titled "Prevention and management of heat-related...
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30-09-2026  FDA Announces New Safety Warning for Adzynma Enzyme Replacement Therapy

<p>The U.S. Food and Drug Administration (FDA) has issued a new boxed warning along with a safety communication concerning Ad...
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29-09-2026  Phase III CELESTIMO Trial Achieves Primary Endpoint in Follicular Lymphoma

<p>Roche has announced that the Phase III CELESTIMO trial evaluating Lunsumio (mosunetuzumab) in combination with lenalidomid...
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28-09-2026  Global Commitment Strengthened at Second UNGA High-Level Meeting on Pandemic Preparedness

On September 25, 2026, a high-level meeting on Pandemic Prevention, Preparedness, and Response (PPPR) was held during the Uni...
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27-09-2026  Second UNGA High-Level Meeting on Pandemic Prevention, Preparedness and Response

The Second UNGA High-Level Meeting on Pandemic Prevention, Preparedness and Response convened world leaders and WHO officials...
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26-09-2026  Summary of CHMP Meeting Highlights (14–17 September 2026)

<p>The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) convened from 14 to 17 September 202...
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25-09-2026  World Patient Safety Day 2026 — Safe Care for Noncommunicable Diseases

On September 17, 2026, the World Health Organization leads the global observance of World Patient Safety Day, focusing on ens...
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24-09-2026  FDA Grants Accelerated Approval to Sevabertinib for NSCLC

<p>On September 9, 2026, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sevabertinib for the tre...
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23-09-2026  FDA Launches Expedited IND Pilot to Accelerate Clinical Development

<p>On September 15, 2026, the U.S. Food and Drug Administration (FDA) announced the launch of an Expedited Investigational Ne...
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22-09-2026  HHS OCR Settles HIPAA Investigation of Ambry Genetics Phishing Attack

<p>The U.S. Department of Health &amp; Human Services Office for Civil Rights (OCR) has announced a settlement resolving a HI...
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21-09-2026  FDA Approval of Imlunestrant with Abemaciclib for Advanced Breast Cancer

<p>The U.S. Food and Drug Administration has approved the combination of imlunestrant (Inluriyo) with abemaciclib for the tre...
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20-09-2026  FDA Approves First Gene Therapy for Pediatric Sanfilippo Syndrome Type A Patients

The U.S. Food and Drug Administration (FDA) has approved Fayuvi, the first gene therapy intended for pediatric patients with ...
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19-09-2026  FDA Approves Tivicay PD (dolutegravir) for Treatment of HIV in Newborns

<p>The U.S. Food and Drug Administration (FDA) has granted approval for Tivicay PD (dolutegravir) as a treatment option for H...
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