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+

Insights+: The US FDA New Drug Approvals in December 2019 and January 2020

The US FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 48 new products so far in 2019 However, there is a significant increase in multiple diseases while the new approvals are helping and advancing the changes to understand, diagnose and treat the diseases Our team…

BySenior EditorFebruary 21, 2020

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PharmaShots’ Key Highlights of First Quarter 2019

The first quarter of 2019 has marked with major events in the pharma & biotech industries. We have gathered the key highlights of the quarter, which was starting with the blockbuster news, where Celgene had acquired BMS for $74B. Moving to the next news, acquisition of Loxo Oncology for $8B, in addition to Spark Therapeutics…

BySenior EditorAugust 4, 2019

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

Insights+: The US FDA New Drug Approvals in December 2019 and January 2020

PharmaShots’ Key Highlights of First Quarter 2019

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