Regulatory Approvals
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ZAMRA approves lenacapavir for HIV prevention in record time
The Zambia Medicines Regulatory Authority (ZAMRA) granted approval on November 4, 2025, completing its review in just 12 working days through an innovative regulatory pathway.
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Solid Biosciences receives FDA rare pediatric disease designation for Friedreich’s Ataxia Gene Therapy SGT-212
The therapy delivers the full-length human frataxin gene using a dual-administration approach that combines direct intradentate nucleus (IDN) injection with intravenous (IV) infusion.
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MHRA approves Roche’s Itovebi for advanced breast cancer treatment
This oral formulation offers a more convenient delivery method compared to intravenous treatments.
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FDA approves GE HealthCare’s AI-powered mammography reconstruction technology
Recon DL is the first mammography technology to combine deep learning with iterative reconstruction methods to enhance digital breast tomosynthesis (DBT) image quality.
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Celltrion’s Eydenzelt gets Health Canada approval for ophthalmology market
Eydenzelt will be available in both pre-filled syringe and vial formats, and it is approved for all the same uses as the original Eylea treatment.
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a2z Radiology AI gains FDA approval for unified abdomen-pelvis CT triage system
Each year in the United States, more than 20 million abdomen-pelvis CT scans are performed, and the volume continues to increase.
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Novartis gains FDA approval for Itvisma gene therapy to treat spinal muscular atrophy
Itvisma works by delivering a functional copy of the survival motor neuron 1 (SMN1) gene through a single, fixed-dose intrathecal injection.