Tags : APR-246

Insights+

Insights+: Breakthrough Therapy Designation by the US FDA in 2020

Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The Breakthrough Designation is granted to the drug candidates as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available […]Read More

Regulatory

Aprea’s APR-246 Receives the US FDA’s Breakthrough Therapy Designation for

Shots: The US FDA has granted BTD for APR-246 in combination with azacitidine to treat myelodysplastic syndromes (MDS) with a susceptible TP53 mutation The BTD supports the development program for APR-246. The company continued its interaction with FDA regarding ongoing P-III study and clinical development program to advance APR-246 APR-246 is a small molecule that […]Read More