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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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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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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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18-09-2026  Join the 9th World One Health Congress in Lisbon

The 9th World One Health Congress, organized by WHO with FAO, UNEP, and WOAH, will be held September 4-7, 2026, in Lisbon. Th...
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17-09-2026  FDA Grants De Novo Marketing Authorization for Aletta Robotic Blood-Draw Device

The U.S. Food and Drug Administration (FDA) has granted marketing authorization for the Aletta robotic blood-draw device on A...
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16-09-2026  AMA Releases CPT® 2027 Code Set

The AMA's publication of the CPT® 2027 code set represents a significant update in healthcare procedural coding. This release...
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15-09-2026  WHO FCTC Engagement at UNITE Global Summit 2026

<p>The Secretariat of the Framework Convention on Tobacco Control (WHO FCTC), part of the World Health Organization, particip...
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14-09-2026  FDA Accelerates Approval of Etcamah for ESR1-Mutated Breast Cancer

<p>On September 4, 2026, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Etcamah (camizestrant) a...
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13-09-2026  FDA Approval of Daraxonrasib (RASONQUE) for Metastatic Pancreatic Adenocarcinoma

<p>On August 26, 2026, the U.S. Food and Drug Administration (FDA) approved daraxonrasib, marketed as RASONQUE, marking a sig...
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11-09-2026  FDA Authorizes First Wearable Device for Continuous Monitoring of Ketone Levels and Blood Glucose

The U.S. Food and Drug Administration (FDA) has authorized a wearable device capable of continuously monitoring both ketone l...
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10-09-2026  FDA Approves First-in-Class Targeted Therapy for Metastatic Pancreatic Cancer

<p>The U.S. Food and Drug Administration (FDA) announced the approval of a first-in-class targeted therapy for metastatic pan...
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