With the first quarter of 2022 now in the rearview mirror, the FDA has approved 10 new drugs (TABLE 1), 4 short of the total this time last year. The decline might add fuel to speculation that the agency is showing more rigour around authorizations following the controversy surrounding ...
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-fam-trastuzumab-deruxtecan-nxki-breast-cancer [9]FDA Approves First Targeted Therapy for HER2-Low Breast Cancer | FDA https://www...
life-threatening skin disease, generalized pustular psoriasis. Retrieved May25, 2022 from, https://www.boehringer-ingelheim.us/press-release/newly-published-results-showed-spesolimab-significantly-improved-signs-and-symptoms
life-threatening skin disease, generalized pustular psoriasis. Retrieved May25, 2022 from, https://www.boehringer-ingelheim.us/press-release/newly-published-results-showed-spesolimab-significantly-improved-signs-and-symptoms
[2] Newly published results showedspesolimab significantly improved signs and symptoms of flares in rare,life-threatening skin disease, generalized pustular psoriasis. Retrieved May25, 2022 from, https://www.boehringer-ingelheim.us/press-release/newly-published-results-showed-spesolimab-significantly-...
2022,we approved 37 new drugs never before approved or marketed in the U.S.,known as“novel”drugs.We also approved p 16、reviously approved drugs in new settings,such as for new indications and patient populations.The 2022 actions,both novel drug approvals and drugs approved in new ...
Now, the Food and Drug Administration(FDA) has approved two drugs that may slow the cognitive decline destroying the lives of millions of Alzheimer’s patients. But both approvals are highly controversial. They were only based on the drugs’ ability to remove plaques (斑块), which were thought...
Overviews of the New Drugs in 2024 Approved by U.S. FDA 2024年美国FDA批准上市新药简介 韩博1,2,3,张庆伟1,2,3* 摘要 2024 年美国FDA 批准上市新药50 个,其中小分子药物31 个,生物制品19 个。根据FDA 批准的新药说明书以及相关数据库和专利检索情况,文章简要介绍了2024 年FDA 批准的上市小分子药物的...
[1] FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic, HR-positive, HER2-negative breast cancer. Retrieved January 17, 2025 from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-...
.Our 2023 New Drug Therapy Approvals Report highlights CDERs“novel”drug approval actions which are for therapies that have not previously been approved in the U.S.The report covers other important CDER actions as well,such as expanding the use or patient population of previously approved drugs...