In late January, a bill to amend the Pharmaceuticals and Medical Devices Act cleared key legislation review processes by the…
REGULATORY
Sakigake Status Goes to World’s 1st Renal-Function Improving Agent, BBB-Penetrating Hunter Syndrome Med and 4 More Drugs
The MHLW said on March 27 that it has granted sakigake fast-track designation, a Japan version of the US FDA’s breakthrough therapy status, to six drugs including what is hoped to be the world’s first renal function-improving agent. The six…
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