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INSIGHTS+

EMA Marketing Authorization of New Drugs in February 2026    

Shots:  The European Commission approved multiple innovative therapies across vaccines, oncology, cardiology, immunology, and rare diseases, including products from Moderna, Hansoh Pharmaceutical, Cytokinetics, ImmunityBio, and GSK  The Committee for Medicinal Products for Human Use also issued positive opinions for late-stage assets from Ipsen, X4 Pharmaceuticals, Novartis, and Moderna, alongside additional recommendations for therapies targeting chronic spontaneous urticaria, WHIM syndrome, pediatric…
March 17, 2026

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NEWS

Fondazione Telethon’s Waskyra Receives the EC Approval for Wiskott-Aldrich Syndrome 

Shots:  The EC has approved Waskyra (etuvetidigene autotemcel), an ex vivo gene therapy for Wiskott-Aldrich Syndrome (WAS)    Waskyra is a single-administration therapy that uses a patient’s CD34+ hematopoietic stem and progenitor cells, modified with a lentiviral vector carrying the WAS gene  The EC’s decision follows a CHMP opinion issued in November 2025 recommending marketing authorization, with the same therapy also approved by…
January 9, 2026

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Merck Kga
NEWS

The NMPA Approves Merck KGaA’s Pimicotinib for Tenosynovial Giant Cell Tumor (TGCT)

Shots: The NMPA has approved Merck KGaA's Pimicotinib (PO) for the treatment of adults with symptomatic TGCT, where surgical resection can lead to functional limitation or relatively severe morbidity Approval was based on the global 3-part P-III (MANEUVER) trial in TGCT pts who require systemic therapy & have not received prior anti-CSF-1/CSF-1R therapy, in which…
December 23, 2025

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INSIGHTS+

EMA Marketing Authorization of New Drugs in October 2025  

Shots:  Innovation in drug development continues to redefine the future of healthcare, fueling bold scientific partnerships and transforming how diseases are understood, managed, and treated across every therapeutic frontier  In October, the EMA issued positive CHMP opinions for two significant therapies: Sanofi’s Wayrilz (rilzabrutinib) for adults with immune thrombocytopenia, and Insmed’s Brinsupri (brensocatib) for the…
November 18, 2025

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NEWS

mAbxience and Abiogen Pharma Enter into a Strategic Licensing Agreement for Biosimilar across Italy

Shots:  mAbxience, majority-owned by Fresenius Kabi and partially by Insud Pharma, has partnered with Abiogen Pharma in a strategic licensing agreement to develop & commercialize a biosimilar in Italy  As per the agreement, mAbxience will hold marketing authorization, while Abiogen Pharma handles commercialization and marketing in Italy  This collaboration leverages mAbxience’s biosimilar development expertise and…
May 26, 2025

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Exclusive_Moitreyee Chatterjee-Kishore_2024
EXCLUSIVE

Decoding Approval: Moitreyee Chatterjee-Kishore from Astellas in an Exclusive Conversation with PharmaShots

Shots:  Recently EC granted Marketing Authorization to Astellas’ VYLOY (zolbetuximab) in combination with chemotherapy for the treatment of patients with advanced gastric and GEJ cancers  Zolbetuximab, a monoclonal antibody designed to target gastric tumor cells that express CLDN18.2 biomarker  Today, at PharmaShots we have Dr. Moitreyee Chatterjee-Kishore the Head of Development, Immuno-Oncology and Cancer Cell…
September 26, 2024

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