FDA chief to speed up approvals of new drugsRonald Rosenberg, Globe Staff
2023年11月,艾贝格司亭α注射液获FDA批准上市,用于成年非髓性恶性肿瘤患者在接受容易引起发热性中性粒细胞减少症的骨髓抑制性抗癌药物治疗时,降低以发热性中性粒细胞减少症为表现的感染发生率。 (4)Motixafortide是BioLineRx旗下的一种合成环肽,靶向CXCR4,于2023年9月获FDA批准上市,适应症为联合filgrastim(粒细胞集...
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FDA Approval The latest news regarding FDA applications, processes, and approval. This section contains releases regarding the Food and Drug Administration’s consideration of new products, drugs, therapies and treatments. Find announcements covering every stage of the FDA application process, from ...
点击“图3”中左侧“Resources for Information on Approved Drugs”,下拉至最底部,界面如下。 ▲图-29 1) 点击“图29”中“New Drugs at FDA”可获得2015年～2022年FDA批准的新药。 ▲图-30 ▲图-31 2) 点击“图29”中“First Generic Drug Approvals”,可检索首个仿制药批准信息。点击药物名称,即可进入...
A hospitalist at the University of Rochester Medical Center calls for more stringent Federal guidelines governing the approval of potential new drugs, in a commentary in the March 10 issue of the Journal of the American Medical Association.
Expected US New Drug Approvals in June 2022 Ahead of us in June,it is anticipated FDA will make decisions on the following four drugs. Drug: spesolimab Company: Boehringer Ingelheim Indication: generalized pustular psoriasis Boehringer Ingelheim’s spesolimab is a humanized, selective antibody th...
5、tion:New Drug Therapy Approvals.This report highlights the role that CDER plays in bringing safe and effective drugs to patients and consumers.2023 was an important year for public health.Perhaps most notably,after more than three years,the U.S.Department of Health and Human Services declarat...
Amylyx's drug approval suggests that the FDA is willing to show the utmost flexibility for life-threatening diseases for which there is an "unmet treatment need," Lynch said. However, the decision could pose further challenges for the agency, she added, because it may not give the compa...
Expected US New Drug Approvals in June 2022 Ahead of us in June,it is anticipated FDA will make decisions on the following four drugs. Drug: spesolimab Company: Boehringer Ingelheim Indication: generalized pustular psoriasis Boehringer Ingelheim’s spesolimab is a humanized, selective antibody th...