Pharmaceutical News
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CHMP Backs AbbVie’s Upadacitinib for Vitiligo and Alopecia Areata
The European Medicines Agency’s Committee has recommended approval of AbbVie’s upadacitinib (RINVOQ®) for treating non-segmental vitiligo and severe alopecia areata in adolescents and adults. Supported by Phase 3 clinical trials, this approval could make it the first systemic medicine for vitiligo in Europe, expanding treatment options for both conditions. Read more
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European Commission Approves Novartis’ Itvisma for Spinal Muscular Atrophy
The European Commission has approved Novartis’ Itvisma®, the first gene replacement therapy for 5q spinal muscular atrophy in children over two, adolescents, and adults. This one-time treatment delivers a functional SMN1 gene, improving motor function. Its efficacy was demonstrated in pivotal clinical trials, benefiting patients across various age groups. Read more
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Roche’s Divarasib Outperforms Approved KRAS G12C Inhibitors in Phase 3 Lung Cancer Trial
Roche’s divarasib showed superior progression-free and overall survival against KRAS G12C inhibitors sotorasib and adagrasib in the Phase 3 Krascendo 1 trial for treated KRAS G12C-mutant lung cancer. The positive results suggest divarasib may become a new standard of care, with plans for regulatory submissions underway. Read more
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FDA Approves Orca Biosystems’ Tregzi, First Regulatory T-Cell Therapy for Blood Cancers
The FDA has approved Orca Biosystems’ Tregzi, the first regulatory T-cell immunotherapy to enhance chronic graft-versus-host disease (GVHD)-free survival in adults with high-risk blood cancers undergoing stem cell transplantation. In a trial, Tregzi showed a significant reduction in chronic GVHD compared to standard transplants, benefiting patient outcomes. Read more
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FDA Grants Priority Review to Roche’s Enspryng for Thyroid Eye Disease
The FDA has granted Priority Review for Roche’s Enspryng® (satralizumab) to treat thyroid eye disease (TED), with a decision due by October 15, 2026. Supported by Phase 3 trials, Enspryng demonstrated significant improvements in proptosis and diplopia, marking it as a potentially groundbreaking at-home treatment option for TED patients. Read more
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Sanofi’s Nexviazyme Meets Phase 3 Goals in Infantile-Onset Pompe Disease
Sanofi’s Nexviazyme achieved all primary and secondary endpoints in the Phase 3 Baby-COMET study for infants with infantile-onset Pompe disease. The study confirmed safety and effectiveness, including invasive ventilator-free survival. Sanofi plans to submit data for U.S. regulatory review, potentially expanding treatment options for this severe condition by late 2026. Read more
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U.S. FDA Tentatively Approves Lupin’s Enzalutamide Tablets
Lupin Limited has received tentative FDA approval for its generic enzalutamide tablets in 40 mg, 80 mg, 120 mg, and 160 mg strengths, paving the way for market entry pending patent resolution. The approval highlights Lupin’s commitment to expanding treatment options for prostate cancer patients while maintaining bioequivalence with the branded Xtandi®. Read more
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FDA, EU Approve Gilead’s Trodelvy for First-Line Metastatic Triple-Negative Breast Cancer
Gilead Sciences’ Trodelvy has received FDA and European Commission approvals for first-line treatment of unresectable advanced or metastatic triple-negative breast cancer. Supported by clinical trials, it reduces disease progression risk significantly and offers greater treatment durability. This marks a pivotal advancement in treatment options for patients with this aggressive cancer subtype. Read more
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Canada Approves AbbVie’s Boey, First Rapid-Onset Neurotoxin for Frown Lines
Health Canada has approved AbbVie’s Boey® (trenibotulinumtoxinE), the first botulinum neurotoxin serotype E for aesthetic use, targeting moderate to severe glabellar lines. This rapid-onset treatment shows effects within eight hours and lasts 14 to 21 days. Clinical trials involving 947 adults demonstrated significant efficacy and patient satisfaction. Read more
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EU Approves AbbVie’s MAVIRET for Acute Hepatitis C Virus Infection
The European Commission approved AbbVie’s MAVIRET for treating acute hepatitis C in adults and children aged three and older, making it the only therapy approved in the EU for both acute and chronic infections. The pivotal Phase 3 study showed a 96.2% sustained virologic response rate, supporting earlier treatment initiation. Read more
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Lilly Completes Centessa Acquisition to Advance Sleep Disorder Pipeline
Eli Lilly has acquired Centessa Pharmaceuticals to enhance its neuroscience portfolio, focusing on orexin receptor 2 agonists for narcolepsy and sleep-wake disorders. This acquisition aims to accelerate the development of novel therapies addressing disrupted sleep signaling, reinforcing Lilly’s commitment to innovative treatments for significant unmet medical needs in neurology. Read more
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FDA, EMA Accept Regeneron’s Cemdisiran for Generalized Myasthenia Gravis
Regeneron’s cemdisiran is advancing as a potential first small interfering RNA therapy for generalized myasthenia gravis, with the FDA and EMA reviewing its application. Approved, it would be uniquely administered subcutaneously every 12 weeks. The NIMBLE trial supports its development, targeting patients with debilitating muscle weakness caused by this autoimmune disease. Read more