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- FDA releases draft guidance to speed cell and gene therapy approvalsThe FDA announced a draft guidance aimed at helping developers bring gene therapies to patients more quickly. It encourages use of publicly available scientific data and existing platform knowledge…
- Fulcrum Therapeutics considers sale after FDA blocks sickle cell drug developmentFulcrum Therapeutics announced it is undertaking a strategic review that could lead to a sale after its lead sickle cell candidate, pociredir, was effectively blocked by the FDA. The agency cited…