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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…
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The EMA has received MAA of Vizz (1.44% aceclidine ophthalmic solution) for the treatment of presbyopia in adults
MAA was supported by the 3 P-III (CLARITY) trials evaluating Vizz (QD) across the US, in which Vizz met all 1 & 2EPs, showing rapid near vision improvement within 30min., lasting up to 10hrs.
Additionally, LENZ…
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The EC has approved Zynyz (retifanlimab) + Pt-based CT for the 1L treatment of adults with metastatic or inoperable locally recurrent SCAC
Approval was based on P-III (POD1UM-303/InterAACT2) trial assessing Zynyz + carboplatin & paclitaxelvs PBO & CT in treatment-naïve SCAC pts
The trial showed a 37% reduction in the risk of progression or…
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The EC has granted conditional approval to Anktiva + Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive NMIBC with CIS, & with/without papillary tumors in all 30 EEA states, based on P-II/III (QUILT-3.032) study (n=100)
Trial showed a 71% CR rate, with a median duration of CR of 26.6mos., plus DoR range was as long as…
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The US FDA grants approval for commercial manufacturing of a biosimilar at Rezon Bio’s Warsaw-Duchnice facility
The FDA approval of the Warsaw-Duchnice facility follows a comprehensive review process and indicates that the site meets regulatory standards for quality systems, technical capabilities, and operational readiness to supply the US market
This approval follows earlier EMA GMP certification and authorization for commercial…
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The European Commission approved multiple therapies across vaccines, rare diseases, endocrinology, and immunology, including products from BioNet, Sanofi, Fondazione Telethon, IntraBio, and Ionis / Otsuka.
The Committee for Medicinal Products for Human Use also issued positive opinions for late-stage assets from UCB and Gedeon Richter, with additional recommendations supporting Sanofi’s Rezurock.
Decisions were backed by strong Phase II/III data…
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The EC has approved STADA & Bio-Thera’s Gotenfia (BAT2506; 50mg/0.5mL & 100mg/mL PFS), a biosimilar version of Simponi (golimumab), in all 30 EEA states, with launch preparations ongoing
Approval was based on extensive analytical, non-clinical & clinical data demonstrating biosimilarity of BAT2506 to Simponi
In May 2024 deal, STADA obtained exclusive commercial rights to Gotenfia…
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The CHMP has recommended Zynyz (retifanlimab) + Pt-based CT as 1L treatment of adults with metastatic or with inoperable locally recurrent SCAC
Opinion was based on P-III (POD1UM-303/InterAACT2) trial assessing Zynyz + carboplatin & paclitaxelvs PBO & CT in treatment-naïve SCAC pts
P-III trial showed a 37% PFS improvement (mPFS: 9.3 vs 7.4mos.); data…
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Corcept has reported P-III (ROSELLA) trial data assessing relacorilant (PO, GR antagonist) + nab-paclitaxel vs nab-paclitaxel in 381 pts with PROC
Trial met its 1EP of OS, showing a 35% reduction in death risk (mOS: 16 vs 11.9mos.), & previously met its PFS endpoint with a 30% reduction in progression risk, as presented at…
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Innovation in drug development continues to reshape patient care across dermatology, cardiology, immunology, oncology, respiratory medicine, and infectious diseases, as regulatory momentum in Europe remains strong toward the end of 2025. Recent EMA actions highlight how advanced biologics, precision small molecules, and next-generation vaccines are translating clinical breakthroughs into real-world impact.
In December 2025, the EMA…

