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Zhejiang Huahai Pharmaceutical has hired a former FDA staffer as its new chief quality officer, as the company struggles to resolve compliance issues with the FDA at a key manufacturing facility.
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In an initiative to increase the efficiency of drug manufacturing in the United States, the FDA has

In the two weeks before and after Independence Day in the U.S., AstraZeneca signed potential billion-dollar licensing deals with…

From Indiana to Iceland, the FDA this week disclosed concerns raised during recent visits to a pair of manufacturing sites with…

The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) and the U.S. | The program looks to support…

Welcome to Fierce Pharma's regulatory tracker for the first half of 2026. | In this tracker, Fierce Pharma is recording the…

As China-developed assets gain more attention from biopharma dealmakers, some industry watchers want to cur | As China-developed…