Insights+: EMA Marketing Authorization of New Drugs in November 2022

Shots: The EMA approved 4 New Chemical Entity (NCE) and 4 Biologic Drugs in November 2022, leading to treatments for patients and advances in the healthcare industry In November 2022, the major highlights drugs were Skyrizi's approval for active crohn's disease, Beyfortus for RSV lower respiratory tract disease PharmaShots has compiled a list of a…

BySenior EditorDecember 28, 2022

INSIGHTS+

Insights+: Breakthrough Therapy Designation by the US FDA in 2019

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 13, 2020

Insights+: EMA Marketing Authorization of New Drugs in November 2022

Insights+: Breakthrough Therapy Designation by the US FDA in 2019

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