Insights+: The US FDA New Drug Approvals in August 2022

The US FDA approved 4 NDAs and 1 BLA in August 2022, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 47 novel products in 2022 In August 2022, the major highlights drugs were Calquence's approval for blood cancer, Imbruvica (ibrutinib) for chronic graft versus host disease in…

BySenior EditorSeptember 15, 2022

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…

BySenior EditorMarch 11, 2021

Insights+: The US FDA New Drug Approvals in August 2022

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

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