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The company wants to shift focus away from when exactly it will seek accelerated approval since the commercial impact is likely to be limited, said Daniel Skovronsky, Lilly’s chief scientific officer. Read More
The FDA has finalized its guidance to help drug sponsors develop population pharmacokinetic (PK) analyses used in drug development to fine-tune dosing regimens. Read More
In a 269-page submission to U.S. Trade Representative, Katherine Tai, the Pharmaceutical Research and Manufacturers of America (PhRMA) spelled out the group’s objections to efforts by the World Health Organization (WHO) and other organizations to expand COVID-19 vaccines and treatments at the expense of intellectual property rights. Read More
To try to avoid supply chain disruptions based on licensing uncertainties, the FDA has issued a proposed rule on the standards for licensing wholesale drug distributors and third-party logistics providers. Read More