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Latest From Eyenovia, Inc.
Plus deals involving SK Biopharmaceuticals, Hikma and Proteovant, Day One/Sprint, Eyenovia/Formosa, Clinigen/CNX, Ikena/Pionyr and more.
Moderna and Life Edit will team up to develop transformative or curative therapies for challenging genetic diseases. Erytech and Pherecydes unveil plan to merge and extend runway into 2024.
Legislative rider effectively reverses Genus court ruling, and now US FDA must treat contrast agents, radioactive drugs and OTC monograph drugs as drugs. However, the agency will have to assess case-by-case whether certain ophthalmic products meet the definition of ‘drug’ or ‘device.’
Sponsors are receiving information requests and complete response letters as a result of the agency’s transition plan, which was made in response to the Genus v. FDA ruling. The decision's aftershocks could reshape the landscape for a number of products, attorney says.
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