Btobioinnovation.com

Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com

SPECIAL REPORT #21.2

Novel Drug Approvals for 2020

According to a report issued by the U.S. FDA’s Center for Drug Evaluation and Research (CDER) the agency has approved  53 new drugs and biological products in 2020. If one adds the two news Emergency Use Authorisations (EUA) for COVID-19 vaccines by Pfizer/BioNTech and Moderna and four CBER approved products, the total U.S. FDA approvals amounts to 59, tying the 2018 record.

Similar to previous years, cancer drugs lead the pack with 19 new approvals.

CDER also approved two new drugs for the treatment of Ebola.

In 2020, 55 biopharmaceutical companies saw one or more of their new drug applications (NDA) being  approved by the U.S. agency including 25 biotechnology companies which received their first ever approval. Eli Lilly, Gilead and Roche got 3 approvals each, while Incyte and Regeneron got 2 each.

Earlier today the European Medicines Agency (EMA) has given a green light for Moderna’s COVID vaccine. The European Commission is expected to grant an EUA later today. Moderna’s vaccine is already authorised in the U.S., Canada and Israel.

Paris, January 6, 2021

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