FDA’s ANDA Approvals
Generic drug approvals and tentative approvals for early September.
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The president’s executive order aims to give smaller companies a leg up over foreign competitors, among other objectives.
No device-related warning letters were released by the US FDA the week of 26 January.
Karyopharm and GSK should soon learn whether the European Medicines Agency will recommend EU approval for their respective products, selinexor and dostarlimab.