Insights+: EMA Marketing Authorization of New Drugs in October 2023

Shots:The EMA approved 2 BLA while 7 new chemical Entity, 6 BLA received positive CHMP opinion in October 2023, leading to treatments for patients and advances in the healthcare industryIn October 2023, the major highlight drugs were Keytruda + trastuzumab 1L treatment of LA unresectable or metastatic HER2+ gastric or GEJ adenocarcinoma &…

BySenior EditorNovember 23, 2023

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Insights+: The US FDA New Drug Approvals in November 2019

The US FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 35 new products so far in 2019. In 2018 FDA approved 59 novel products including 42 New Chemical Entities and 17 Biologics while breaking its last year's record of approvals. However, there is a significant…

BySenior EditorDecember 13, 2019

Insights+: EMA Marketing Authorization of New Drugs in October 2023

Insights+: The US FDA New Drug Approvals in November 2019

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Insights+: EMA Marketing Authorization of New Drugs in October 2023

Insights+: The US FDA New Drug Approvals in November 2019

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