
Aardvark released exploratory data from its stopped Phase 3 HERO trial in Prader-Willi syndrome after FDA lifted the hold, and plans a redesigned Phase 3.
A recently completed study reported that the 505(b)(2) approval pathway for new drug applications in the US has not led to shorter approval times.
A recently completed study conducted by Tufts CSDD reported that the 505(b)(2) approval pathway for new drug applications in the US, aimed at avoiding the duplication of studies performed on a previously approved drugs, has not led to shorter approval times.
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