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Developing a first-in-class small molecule drug for inflammatory disease

European Pharmaceutical Review

MyMD plans to present the data to the US Food and Drug Administration (FDA) and intends to advance the clinical programme for MYMD-1 into Phase III either alone or through partnership. There are no FDA-approved medications to treat sarcopenia. Why is a TNF-α inhibitor promising as a first-in-class therapeutic for sarcopenia/frailty?

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

FDA Official Warns Manufacturers of Common Problems Found in Aseptic Operations.” www.raps.org/news-and-articles/news-articles/2023/3/fda-official-warns-manufacturers-of-common-problem 25 US Food and Drug Administration Center for Drug Evaluation and Research. September 2022. 25%20from%202022%20to%202027 24 Eglovitch, J. 7 March 2023.