FDA Grants Accelerated Approval to Ultragenyx's Genglycos for Rare GSDIa
Gene therapy becomes the first treatment designed to directly address the underlying cause of glycogen storage disease type Ia in patients aged eight and older.
Paediatric Patients | 21/08/2026 | By News Bureau
Chugai Files for Expanded Tecentriq Use in MSI-High Colon Cancer in Japan
Chugai Pharmaceutical has filed a Japanese regulatory application seeking an expanded Tecentriq indication for adjuvant treatment of MSI-High colon cancer. The filing is backed by Phase 3 ATOMIC data showing three-year disease-free survival of 86.3 percent with Tecentriq plus mFOLFOX6, versus 76.2 percent with chemotherapy alone.
Paediatric Patients | 17/08/2026 | By News Bureau
Pharming Launches Joenja in Japan for APDS Patients Aged 4 and Older
Pharming has launched Joenja in Japan for APDS patients aged 4 years and older, making Japan the first market to offer the treatment commercially to children aged 4–11.
Paediatric Patients | 14/08/2026 | By News Bureau
European Commission Expands Bracco's Vueway Approval to Infants and Neonates
Bracco Imaging secures EU approval to extend Vueway’s use to infants and neonates, enhancing safe and effective MRI diagnostics for young patients.
Paediatric Patients | 28/01/2026 | By News Bureau | 174
European Commission Approves Teizeild to Delay Onset of Type 1 Diabetes
Teizeild (teplizumab) becomes the first disease-modifying therapy approved in the EU to delay progression to stage III type 1 diabetes in eligible adults and children aged eight and above.
Paediatric Patients | 13/01/2026 | By News Bureau | 276
Lupin Receives Tentative Approval from US FDA for its HIV treatment tablets
Lupin has received tentative US FDA approval for Bictegravir, Emtricitabine and Tenofovir Alafenamide Tablets to treat HIV, bioequivalent to Gilead’s Biktarvy, for adults and paediatric patients over 25 kg.
Paediatric Patients | 25/09/2025 | By Dineshwori | 243
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