As clinical trials become increasingly complex and technology-driven, the need for smarter strategies, stronger collaborations, and patient-centric innovation has never been greater. From decentralized clinical trials and artificial intelligence to advanced data management and evolving regulatory frameworks, the clinical research landscape is undergoing a significant transformation.
Global Clinical Trials Connect 2027 aims to bring together…
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July 2026 witnessed strong momentum across the biosimilars landscape with major regulatory approvals, including Ennumo (US FDA), Garzulys (US FDA), Yesintek Autoinjector (Health Canada), and FDA/EMA acceptance of PB016, alongside commercial launches of Byooviz, Osvyrti, and Jubereq, expanding treatment options across oncology, ophthalmology, immunology, osteoporosis, diabetes, and inflammatory diseases.
Strategic collaborations and licensing agreements between Orion Pharma–Shilpa Biologicals, Polpharma–Teva, Samsung Bioepis–Teva, Formycon–OneSource Specialty Pharma, and Organon–Samsung Bioepis strengthened…
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The European Medicines Agency (EMA) advanced multiple marketing authorizations and positive opinions in June 2026 across oncology, neurology, rare diseases, metabolic disorders, and infectious diseases, involving companies including Amgen, Immedica, Sanofi, Arrowhead Pharmaceuticals, Acadia Pharmaceuticals, and Zambon.
European Commission approvals included Imdylltra for extensive-stage small cell lung cancer (ES-SCLC), Zepzelca + Tecentriq as a first-line maintenance therapy for ES-SCLC, Cenrifki for secondary progressive…
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The US FDA approved three notable therapies in June 2026, spanning diagnostic imaging, infectious diseases, and ophthalmology, highlighting continued progress in precision diagnostics, antimicrobial innovation, and rare disease treatment.
Key approvals included Ambelvist (enhanced MRI detection of lesions), Utebzi (complicated urinary tract infections, including pyelonephritis), and Lumvoa (thyroid eye disease), expanding treatment and diagnostic options for patients with diverse clinical…
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June 2026 saw strong biosimilar momentum with key approvals and regulatory milestones, including Ranluspec (US FDA), Tofidence sBLA (US FDA), Liyoubao (NMPA), Zandoriah (EC), and multiple ANVISA approvals, alongside submissions for CT-P55 (Health Canada) and ADL-018 (Health Canada), expanding treatment options across immunology, ophthalmology, oncology, osteoporosis, and reproductive medicine.
Strategic collaborations between Chime Biologics–Daewoong, Polpharma Biologics–PSI CRO, Xbrane–JOINN, Samsung Bioepis–Organon, and Orion Pharma–Shilpa Biologicals advanced global biosimilar development and commercialization.
Commercial and clinical progress accelerated with the EU launch of Ahzantive, Canadian launches of Bildyos and Tuzemty, FDA acceptance of multiple BLA submissions, first patient dosing of HLX17, and positive late-stage data for SB27 and SPD8, highlighting continued global biosimilar market expansion.
Celltrion Seeks…
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The European Medicines Agency (EMA) advanced multiple marketing authorizations and positive opinions in May 2026 across pulmonology, oncology, rare diseases, immunology, aesthetics, and endocrinology, involving companies including Boehringer Ingelheim, Novartis, AstraZeneca, AbbVie, Pharming, and Amgen.
CHMP positive opinions included Jascayd for idiopathic pulmonary fibrosis and progressive pulmonary fibrosis, Vijoice for PIK3CA-related overgrowth spectrum (PROS) disorders, Camizestrant (Etcamah) for ESR1-mutated advanced breast cancer,…
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This edition explores Digital Vigilance: AI Enhancing Post-Market Safety Monitoring, highlighting how artificial intelligence, real-world data, and digital listening technologies are transforming pharmacovigilance into a proactive, predictive, and patient-centric discipline.
Through expert perspectives, cover stories, and regulatory insights, we examine the opportunities and challenges of AI-driven safety surveillance—from social media signal detection and real-world…
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The US FDA approved eight therapies in May 2026 across oncology, cardiovascular disease, infectious diseases, anesthesia, and antimicrobial resistance, reflecting continued regulatory momentum in addressing both rare and prevalent diseases.
Key approvals included Veppanu (breast cancer), Beqalzi (mantle cell lymphoma), Baxfendy (hypertension), Hepcludex (HDV infection), Decnupaz (BPDCN), Zaynich (cUTI), Cypsedo (general anesthesia), and Xocova (COVID-19 PEP).
Overall, May 2026 underscored the FDA’s commitment to advancing innovative medicines, precision therapies, and expanded patient access,…
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May 2026 saw strong biosimilar momentum with key approvals including Bevqolva (Health Canada), Langlara and Immgolis/Immgolis Intri (US FDA), Bysumlog and Dazparda (EC), and Eyzanfy (MFDS), expanding competition across oncology, diabetes, immunology, and ophthalmology.
Strategic progress continued with Henlius’ FDA IND clearance for HLX05-N, alongside partnerships between IQVIA–Kexing Biopharm and Polpharma–Tuteur, supporting global development and commercialization efforts.
Commercialization accelerated through the EU launches of FYB203 and Opuviz, as well as Samsung Bioepis’ ustekinumab biosimilar launch in Japan,…
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IQVIA is expanding its collaboration with Kexing Biopharm to advance a global multi-product biosimilar development and commercialization program
As part of the collaboration, IQVIA will provide end-to-end development, regulatory, analytics, and commercialization support to accelerate Kexing’s global biosimilar expansion while maintaining high quality and scientific standards
The collaboration also integrates IQVIA’s AI-enabled clinical trial capabilities to streamline protocol design, site selection,…

