Society and culture: add pending EU
Okumaya devam et...
← Previous revision | Revision as of 02:24, 27 April 2024 |
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| === Legal status === | === Legal status === |
| Capivasertib was approved for medical use in the United States in November 2023.<ref name="FDA Truqap" /> The FDA granted the application for capivasertib [[FDA Fast Track|fast track]] designation.<ref name="New Drug Therapy Approvals 2023" /> | Capivasertib was approved for medical use in the United States in November 2023.<ref name="FDA Truqap" /> The FDA granted the application for capivasertib [[FDA Fast Track|fast track]] designation.<ref name="New Drug Therapy Approvals 2023" /> |
| In April 2024, the [[Committee for Medicinal Products for Human Use]] (CHMP) of the [[European Medicines Agency]] adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Truqap, intended for the treatment of locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations.<ref name="Truqap EPAR"> The applicant for this medicinal product is AstraZeneca AB.<ref name="Truqap EPAR">{{cite web | title=Truqap EPAR | website=[[European Medicines Agency]] | date=25 April 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/truqap | access-date=27 April 2024}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> | |
| ==References== | ==References== |
Okumaya devam et...