Our infographic breaks down the bumper crop.
(Also see "What Pandemic Effect? US FDA’s 2021 Approval Class Is Off To Strong Start With 60+ Novel Candidates" - Pink Sheet, 9 February, 2021.)
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The European Medicines Agency has OKd 10 new medicines for EU-wide approval, including a CAR-T therapy for treating acute lymphoblastic leukemia. Two drugs were, however, rejected.
In the infrequent cases when EU authorization precedes US FDA approvals of new products, biologics manufacturing issues are usually to blame, a Pink Sheet analysis found.
The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.
Autolus’s CAR T therapy obe-cel is among the medicines that are this week due for an opinion by the European Medicines Agency on whether they should be marketed in the EU.
In the infrequent cases when EU authorization precedes US FDA approvals of new products, biologics manufacturing issues are usually to blame, a Pink Sheet analysis found.
The FDA’s advisors split on whether to update COVID-19 vaccines for the fall. The agency refused to discuss the impact of the new vaccine framework on availability.
The lack of a formal analysis of efficacy in castration-resistant prostate cancer patients without HRR mutations doomed Pfizer’s Talzenna at the US FDA's Oncologic Drugs Advisory Committee, as FDA oncology chief Richard Pazdur says chance cannot be ruled out.
