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FDA Extends Review Deadline For Regeneron/Sanofi’s Dupixent For ‘Smoker’s Lungs’ Disease

By Vandana Singh
May 31, 9:23 AM
The FDA extends the target action date for reviewing Dupixent as an add-on treatment for uncontrolled COPD to September 27, 2024. This follows the submission of additional efficacy analyses from pivotal trials. European Medicines Agency also supports Dupixent for COPD.

REGN

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EXCLUSIVE: Telo Genomics’ Smoldering Multiple Myeloma Prognostic Test Predicts Risk Of Disease Progression, Study Shows

By Vandana Singh
May 30, 8:15 AM
American Journal of Hematology accepts Telo Genomics' study on TeloViewSMM, a prognostic test for smoldering multiple myeloma. The test showed 85% positive and 73% negative predictive values, offering non-invasive liquid biopsy

TDSGF

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Nvidia Is Up 186% From A Year Ago, Yet These 7 Stocks Have More Than Doubled Their Returns Over The AI Chipmaker

By Piero Cingari
May 29, 5:56 PM
NVIDIA Corp. (NASDAQ:NVDA) has been the standout tech stock of the past year, leading the Nasdaq 100 index in the performance ranking.

ANF

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Ikena Oncology Discontinues IK-930 Program And Cuts Workforce, Analyst Calls It ‘Disappointing’

By Vandana Singh
May 29, 3:33 PM
Ikena Oncology halts its IK-930 program after reviewing clinical data and resources, focusing on the novel MEK-RAF molecular glue, IK-595.

IKNA

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FDA Conditionally Approves Eli Lilly’s Thyroid Cancer Drug For Pediatric Patients With Certain Mutations

By Vandana Singh
May 29, 3:02 PM
Accelerated FDA approval for Eli Lilly's selpercatinib (Retevmo) in pediatric patients aged 2+ with advanced/metastatic thyroid cancer & solid tumors carrying RET mutations or fusions.

LLY

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Biohaven Stock Stumbles As Protein-Degrading Drug Falls Short Of Expectations In Early-Stage Study

By Vandana Singh
May 29, 2:47 PM
Biohaven shares drop as interim data from the Phase 1 study of BHV-1300 fell short of investor expectations.

ARGX

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Johnson & Johnson’s Drug Seltorexant Aces Late-Stage Depression Trial

By Vandana Singh
May 29, 12:55 PM
Johnson & Johnson reported successful Phase 3 trial results for seltorexant, an investigational treatment for major depressive disorder with insomnia.

JNJ

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Amgen Secures FDA Nod For Rare-Disease Treatment Biosimilar Based On AstraZeneca’s Drug

By Vandana Singh
May 29, 12:51 PM
The FDA has approved Amgen's Bkemv as the first interchangeable biosimilar to AstraZeneca's Soliris for treating rare diseases.

AMGN

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Why Is Medical Coating Specialist Surmodics Trading Higher On Wednesday?

By Vandana Singh
May 29, 10:48 AM
Surmodics will be acquired by GTCR for $43.00 per share, totaling $627 million. This 41.1% premium reflects Surmodics' advancements in surface modification for medical devices and IVD technologies.

SRDX

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Amid Ozempic’s ‘Miracle’ Weight-Loss Craze, This Company Peaked Over 100% In Tuesday Pre-Market After Receiving Approval For Obesity Treatment

By Pooja Rajkumari
May 29, 7:49 AM
The approval comes at a time when global demand for weight loss drugs like Ozempic and WeGovy is increasing.

RSLS

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