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A joint bid to deploy Proteus Digital Health Inc.'s ingestible sensor with Tokyo-based Otsuka Pharmaceutical Co. Ltd.'s antipsychotic drug, Abilify, was met with a complete response letter from the FDA.

The FDA's slow pace of developing a U.S. biosimilar path that already trails that of other markets has drawn sharp rebukes from Congress and critics, but the regulator isn't the only force shaping the path.

Shares of Catalyst Pharmaceuticals Inc. dove 49.2 percent on Tuesday after the company said the FDA will require it to submit positive results from an additional study of Firdapse in patients with Lambert-Eaton myasthenic syndrome prior to accepting its NDA.

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