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News about "supplemental New Drug Application (sNDA) "
IntraBio Submits EMA Variation Application for AQNEURSA in Ataxia-Telangiectasia
IntraBio has submitted a variation application to the European Medicines Agency (EMA) for AQNEURSA as a treatment for Ataxia-Telangiectasia. If approved, it would become the first authorised therapy for this disorder in the European Economic Area.
Supplemental New Drug Application (sNDA) | 06/06/2026 | By News Bureau
Bristol Myers Squibb Secures FDA Priority Review for Camzyos
The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s supplemental New Drug Application (NDA) for Priority Review (PR) of Camzyos (mavacamten) to treat adolescents with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
Supplemental New Drug Application (sNDA) | 02/06/2026 | By News Bureau
US FDA Recommends AstraZeneca's TRUQAP for PTEN-Deficient Prostate Cancer
US Food and Drug Administration (FDA) advisory panel backs TRUQAP (capivasertib) with abiraterone and ADT for PTEN-deficient metastatic hormone-sensitive prostate cancer, based on positive phase 3 CAPItello-281 results showing favorable benefit-risk.
Supplemental New Drug Application (sNDA) | 01/05/2026 | By News Bureau
Pharming Gets Complete Response Letter from US FDA for Joenja
The US FDA issued a Complete Response Letter to Pharming Group for the supplemental NDA for Joenja, citing the need for additional information to support its use in children aged four to 11 years with activated phosphoinositide 3-kinase delta syndrome, a rare primary immunodeficiency.
Supplemental New Drug Application (sNDA) | 02/02/2026 | By News Bureau | 201
Novo Nordisk Files for FDA Approval of Wegovy Injection 7.2 mg
Novo Nordisk has filed an sNDA with the US FDA for a 7.2 mg dose of Wegovy, aiming to offer a higher-dose option for adults with obesity. The application, supported by STEP UP trial data showing 20.7 percent average weight loss, will be reviewed under the FDA’s expedited CNPV pathway.
Supplemental New Drug Application (sNDA) | 29/11/2025 | By Dineshwori | 381
Daiichi Sankyo Files sNDA in Japan for ENHERTU Plus Pertuzumab in HER2-Positive Breast Cancer
Daiichi Sankyo has filed a supplemental NDA in Japan for ENHERTU plus Pertuzumab in HER2-positive breast cancer. If approved, this therapy could enter the first-line metastatic setting and has the potential to become a new standard of care.
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Supplemental New Drug Application (sNDA) | 08/10/2025 | By Dineshwori | 549
GSK to submit label update for Wellcovorin at US FDA's request
GSK will file an sNDA with the US FDA to update Wellcovorin’s label to include Cerebral Folate Deficiency, following the agency’s request under its initiative to repurpose older drugs for chronic conditions.
Supplemental New Drug Application (sNDA) | 24/09/2025 | By Dineshwori | 237
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