Company focused on obtaining approval for outpatient (at-home) use of IGALMI® for the acute treatment of agitation associated ...

2025年7月3日，迪哲医药（股票代码：688192.SH）宣布，舒沃哲（ZEGFROVY，通用名：舒沃替尼片）的新药上市申请（New Drug ...

经济观察网讯 据迪哲Dizal微信公众号7月3日消息，迪哲医药（股票代码：688192.SH）宣布，舒沃哲®（ZEGFROVY®，通用名：舒沃替尼片）的新药上市申请（New Drug Application，NDA），正式获得美国食品药品监督管理局（FDA）批准，用于既往经含铂化疗治疗时或治疗后出现疾病进展，并且经FDA批准的试剂盒检测确认，存在表皮生长因子受体（EGFR）20号外显子插入突变（e ...

Tidmarsh, who has founded and served as CEO of several biotech companies, will lead a crucial FDA division that reviews the ...

Sotyktu (deucravacitinib) has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 6, 2026.

The submission is supported by four Phase III clinical trials, which showed that icotrokinra demonstrated significant skin ...

The new drug application is supported by 48-week data from the Phase III MK-8591A-051 and MK-8591A-052 trials, which showed ...

An FDA advisory panel will meet July 18 to consider a supplemental new drug application for the antipsychotic brexpiprazole, ...

Aldeyra Therapeutics (NASDAQ:ALDX) announced on Thursday that the U.S. Food and Drug Administration (FDA) accepted for review ...

Potential NIH and FDA cuts could lower the number of new drugs that come to market in the next three decades, according to a ...

The Investigational New Drug (IND) process was established to ensure that the FDA is informed of any new treatment before use in humans. The process is now used for approval rather than notification.

President Donald Trump's proposed budget cuts to the National Institutes of Health would eventually result in fewer drugs on ...