foods from genome-edited plants are subject to the same FDCA requirements as other foods, and FDA’s interpretation of the FDCA as explained in the NPV Policy applies to foods from genome-edited plants. Since FDA issued the NPV Policy, Congress added section 403(w) to the FDCA, whi...
Lurie et al. published in the June 10, 2015 issue of the "British Medical Journal."doi:10.1007/s40274-015-2209-4NoneSpringer International PublishingPharmacoEconomics & Outcomes News
[1]https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imetelstat-low-intermediate-1-risk-myelodysplastic-syndromes-transfusion-dependent [2]https://ir.geron.com/investors/press-releases/press-release-details/202...
[1]https://wwwext.amgen.com/newsroom/press-releases/2024/06/fda-approves-blincyto-blinatumomab-in-cd19positive-philadelphia-chromosomenegative-bcell-precursor-acute-lymphoblastic-leukemia-ball-in-the-consolidation-phase [2]https://www....
参考资料: FDA Press Releases. 2016 FDA Approved Drugs Novel Drug Approvals for 2016 CDER New Drug Review:2016 Update 2016年美国FDA新药审评一览 干货!2016年FDA上市新药深度盘点 2016年FDA批准的19个新药:小分子锐减,抗体热度依旧
1.AstraZeneca. Farxiga approved in the US for the treatment of paediatric type-2 diabetes. News release. June 12, 2024. Accessed June 12 2024. https://www.astrazeneca.com/media-centre/press-releases/2024/farxiga-approved-in-the-us-for-the-treatment-of-paediatric-type-2-diabetes.html ...
[1] Ipsen confirms U.S. FDA grants priority review for New DrugApplication for elafibranor for the treatment of rare cholestatic liverdisease, PBC. Retrieved December 8, 2023, fromhttps://www.ipsen.com/press-releases/ipsen-confirms-u-s-fda-grants-priority-review-for-new-drug-application-for...
[1] Ipsen confirms U.S. FDA grants priority review for New Drug Application for elafibranor for the treatment of rare cholestatic liver disease, PBC. Retrieved December 8, 2023, from https://www.ipsen.com/press-releases/ipsen-confirms-u-s-fda-grants-priority-review-for-new-drug-application...
(linaclotide) for Functional Constipation in Children and Adolescents Ages 6-17 Years-Old. Retrieved February 13, 2023 from https://investor.ironwoodpharma.com/press-releases/press-release-details/2023/Ironwood-Pharmaceuticals-Announces-FDA-Filing-Acceptance-and-Priority-Review-of-Supplemental-New-Drug-...
Jump toNews Releases: Go Latest Jan 01, 2025, 23:52 ETFDA Grants Orphan Drug Designation to MicuRx's MRX-5 for NTM Infections Shanghai MicuRx Pharmaceutical Co., Ltd. ("MicuRx",688373.SH) announced that MRX-5, its self-developed anti-infection drug, has been granted Orphan... ...