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INSIGHTS+

Key Biosimilars Events of April 2026 

Shots:  Regulatory momentum stayed strong in April 2026, with key approvals including Poherdy (EC), Tuyory (EC), and multiple denosumab biosimilars in Canada, alongside NMPA IND clearances for Henlius’ HLX319 and HLX05-N and Mabwell’s Maiweijian sBLA acceptance.  Strategic activity expanded globally through Mochida–Qilu and Mabwell partnerships, while major M&A deals, Amneal–Kashiv and Sun Pharma–Organon, signaled growing biosimilar consolidation.  Pipelines and commercialization progressed with CuraTeQ’s P-III success for BP11 and Biocon’s US launch of Bosaya and Aukelso,…
13 hours ago

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INSIGHTS+

The US FDA New Drug Approvals in February 2026 

Shots:  Approval momentum strengthened in February 2026, with the US FDA clearing four new therapies across dermatology, psychiatry, and rare pediatric disorders highlighting both volume and therapeutic impact.  Four notable therapies crossed the regulatory finish line, Acrotech Biopharma and Otsuka Pharmaceutical’s Adquey for mild-to-moderate atopic dermatitis, Vanda Pharmaceuticals’ Bysanti for acute bipolar I disorder and schizophrenia, Immedica Pharma’s Loargys for ARG1-D–related hyperargininemia, and Ascendis Pharma’s Yuviwel to improve growth in children with achondroplasia  Overall, February 2026 reflected…
March 10, 2026

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INSIGHTS+

Disease of the Month – Hemolytic uremic syndrome 

Shots:  Hemolytic uremic syndrome (HUS) is a serious, potentially life-threatening condition in which damage to the small blood vessels in the kidneys interferes with their ability to function properly  With the Disease of Month report, we break down complex medical topics into clear, meaningful insights for global readers. By highlighting conditions that impact communities worldwide, we aim to keep our readers informed,…
December 30, 2025

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EXCLUSIVE

Exclusive: A Stimulating Dialogue with Edmund Ben Ami, Co-Founder & CEO of NeuraLight 

Shots:  Given the high variability and subjectivity of traditional clinical scales, there is an urgent need for objective biomarkers to assess CNS disease progression more reliably    NeuraLight is at the forefront of precision neurology, developing objective and sensitive biomarkers that bring greater accuracy and consistency to CNS research    In this exclusive conversation, Edmund…
October 14, 2025

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