Hainan Boao Lecheng Pilot Zone Issues Exit Mechanism Rules for Clinical Translation of New Biomedical Technologies – Full‑Process Framework for Suspension, Exit and Resumption
The Hainan Boao Lecheng International Medical Tourism Pilot Zone has released the "Implementation Rules for the Exit Mechanism of Clinical Translation and Application of New Biomedical Technologies" (the "Rules"), aiming…
Bayer’s Sevabertinib Granted FDA Accelerated Approval – First‑Line Oral TKI for HER2‑Mutant Non‑Small Cell Lung Cancer
Bayer AG (ETR: BAYN) announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to sevabertinib as a first‑line treatment option for adult patients with locally advanced or metastatic non‑squamous non‑small cell lung cancer (NSCLC) whose tumors…
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Boji Medical and Zhejiang Maiyata Sign Strategic Partnership – Leading China CRO Joins Microbiome Innovator to Advance Live Biotherapeutic Products
Boji Medical Technology Co., Ltd. (SHE: 300404), a leading China‑based Clinical Research Organization (CRO), and Zhejiang Maiyata Microbial Inspection Intelligent Technology Co., Ltd. held a strategic cooperation signing ceremony at…
NMPA Proposes Optimized Process Validation Requirements for Innovative Chemical Drugs – Draft Policy Incentivizes Global Simultaneous Filing and Launch in China
China's National Medical Products Administration (NMPA) issued the Announcement on Further Optimizing the Requirements for Application Materials of Process Validation for Innovative Chemical Drugs (Draft for Comments), seeking public feedback…
