日前，作者注意到FDA于2025年10月23日更新了新药申请（NDA）或生物制品许可申请（BLA）（包括其增补）的立卷审查指南MAPP ...

Rose McGowan recenlty confessed that she tricked Harvey Weinstein, refused NDA, and reportedly used $100K as proof of his ...

Graham Kates is an investigative reporter covering criminal justice, privacy issues and information security for CBS News Digital. Contact Graham at KatesG@cbsnews.com or grahamkates@protonmail.com In ...

格隆汇1月9日丨康宁杰瑞制药-B(09966.HK)公告，中国国家药品监督管理局已正式受理KN035(恩沃利单抗注射液)(商标名：恩维达®)联合吉西他滨和奥沙利铂("GEMOX")方案，用于一线治疗不可切除或转移性胆道癌("BTC")的新药上市申请( ...

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Mineralys (MLYS) is transitioning to a pre-commercial stage, supported by robust Phase 3 data and a strengthened cash position of $593.6 million.