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Health Canada has approved Gazyva (obinutuzumab) for adults with active lupus nephritis receiving standard therapy
Approval was based on P-II (NOBILITY) & P-III (REGENCY) trials, where in REGENCY (n=271), 46.4% on Gazyva + SoC achieved CRR vs 33.1% on SoC. Gazyva’s safety profile was consistent with its well-established profile from haematology-oncology indications
Gazyva is…
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The EC has approved the Arexvy RSV vaccine for adults ≥18 yrs in Europe. While it was previously authorized only for adults ≥50 yrs at risk
The adjuvanted RSV vaccine includes a stabilized form of a protein from the respiratory syncytial virus (RSV), called the prefusion F protein (RSVPreF3), combined with GSK’s AS01E adjuvant,…
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Neurocrine Biosciences has initiated a P-II study of investigational NBI-1065890 in adults with TD
P-II study of NBI-1065890 will enroll ~100 adults with TD, evaluating efficacy, safety, and tolerability, with the 1EP being change from baseline in Abnormal Involuntary Movement Scale (AIMS) total score at Wk 8
NBI-1065890 is a selective oral VMAT2 inhibitor…
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Milestone Pharma has reported Cardamyst (Etripamil) is now available in the US for paroxysmal supraventricular tachycardia (PSVT); national sales force to be deployed in mid-Feb 2026
Cardamyst (Intranasal) is a Bidose (BDS) Liquid Nasal Spray System, a self-administered calcium channel blocker nasal spray for rapid response to PSVT, launching with a patient assistance program…
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MS Pharma has signed a strategic partnership with Hetero to localize five established biosimilars across key areas, including oncology, immunology, and hematology, in the MENA region
The exclusive agreement will be implemented through El Kendi (MS Pharma Group’s Algeria affiliate) and Hetero Biopharma, a subsidiary of Hetero Group
This marks Hetero’s first local partnership in Algeria, supporting…
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EMA approvals in 2025 reinforce a biology-first regulatory standard, favoring mutation-exact, genotype-defined, and severity-weighted therapies that narrow indications, elevate rare diseases, and reward durability of benefit over rapid market expansion
Convenience at the EMA is no longer cosmetic, it is integral to benefit–risk assessment, with oral, subcutaneous, and low-burden dosing strategies increasingly tied to adherence, long-term outcomes,…
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Zydus Lifesciences has reported Tishtha, biosimilar version of Opdivo (Nivolumab), is now available in the India
Tishtha will be available in 100 mg and 40 mg strengths
Nivolumab is a mAb targeting PD-1 to enhance anti-tumor immune responses and is approved worldwide for cancers, including melanoma, mesothelioma, head and neck, and urothelial carcinoma
Ref: Zydus | Image: Zydus | Press Release
Related News: Shanghai Henlius Receives the US FDA…
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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…
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The EMA has validated the Type II Variation MAA for Enhertu (trastuzumab deruxtecan) in combination with pertuzumab for the 1L treatment of patients with HER2+ positive unresectable or metastatic breast cancer.
MAA was supported by P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± Perjeta vs taxane, trastuzumab & Perjeta (THP) in HER2+ metastatic breast cancer…
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The company has reported dosing of the first patient in the US P-III (BiPASS) trial evaluating its PSMA-PET imaging agents, Illuccix and Gozellix, for use in the initial diagnosis of prostate cancer
BiPASSa P-III study enrolling 250 pts in the US and Australia to support marketing authorization of 68Ga-PSMA-PET in the pre-biopsy setting
Building…

