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Latest From CardioMEMS, Inc.
Even before a new law granted FDA authority to require studies be underway before accelerated approval, review divisions have, in some cases, given sponsors years of advance notice on expectations around study timing, according to a Pink Sheet review of NME accelerated approvals.
The company is discontinuing its lead clinical programs and planning major layoffs as it seeks to reprioritize its pipeline and extend cash runway.
Omnibus legislation requires FDA to issue guidance documents and hold public workshops on clinical trial diversity, but it does not give the agency authority to mandate postmarketing studies if a preapproval trial falls short of demographic diversity goals.
The first BCMA-targeting agent to gain approval in myeloma never became the blockbuster for which GSK had hoped, but Blenrep appears to have set a new standard for speed of voluntary withdrawal of an accelerated approval drug after a confirmatory trial failure.
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