FDA announces major reforms to streamline biosimilar approvals, potentially saving Americans billions on prescription drug ...
A long-running confirmatory trial of two of Sarepta Therapeutics’ Duchenne muscular dystrophy drugs has missed its main goal.
Shares of Sarepta Therapeutics Inc. plunged in extended trading Monday after the biotechnology company disclosed disappointing drug-trial data, which could lengthen the timeline of the regulatory ...
Developers of biosimilars, medicines that are near-identical copies of biologic drugs, will no longer be required to conduct clinical trials to prove effectiveness.
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