These categories are not mutually exclusive, meaning a drug can be granted expedited review status in more than one of these programs. Figure 5 illustrates the breakdown of expedited review designations for FDA-approved drugs from 2010 to 2019. For example, in 2019, of the 48 drugs approved,...
Biogen has criticized Medicare’s decision, saying the added requirements “would significantly restrictand delay patient access to an FDA-approved therapy for a progressive disease.” But thecore of the issuesurrounding this drug is simple: Does it actually work? An ...
Food and Drug Administration (FDA)has approved a debatable Alzheimer's treatment, the first that promises to slow the disease's destruction in the brain.The drug, aducanumab, is also the first new Alzheimer's treatment approved since2003.However, in 2019, aducanumab was nearly abandoned after ...
FDA Approves a Second Drug for the Prevention of Influenza A and B in Adults and ChildrenThe U.S. Food
aducanumab was nearly abandoned after it appeared unlikely to succeed in two clinical trials.But after reanalyzing more data,the drug's developer Biogen saw signs indicating the drug might work,and decided to pursue FDA approval.(这种名为aducanumab的药物也是2003年以来批准的首个新的阿尔茨海默病治疗...
FDA批准tirzpatide:一种有效的2型糖尿病新药 图片上传失败 重试 美国食品和药物管理局(FDA)已经批准了一种治疗2型糖尿病的新型同类药物。这种药物被称为tirzapente。 一个人在皮肤下每周注射一次。 它具有双重作用,降低血糖并支持减肥比目前可用的药物更好地治疗这种情况。
FDA approves new treatment option for late-stage breast cancer The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate) to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease … (click PDF to rea.....
The U.S. Food and Drug Administration(FDA) has approved a new class of hearing aid devices, which do not require a medical exam. That means Americans will be able to buy hearing aids later this year without seeing a doctor or receiving a medical examination. The devices are designed for...
据美国FDA官方通告,Voydeya(danicopan)于4月1日获得批准,作为标准疗法补体因子C5抑制剂Ultomiris(ravulizumab)或Soliris(eculizumab)的附加疗法,用于治疗成人阵发性睡眠性血红蛋白尿(PNH)的血管外溶血(EVH)。 Voydeya是由阿斯利康研发的一款口...
Earlier this year, European regulators approved a similar gene therapy for hemophilia A. That drug, from drugmaker BioMarin, is still under review at the FDA.