Btobioinnovation.com 

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

SPECIAL REPORT 25.18

We wish all our readers and followers a Happy and Prosperous Year 2026

US FDA Novel Drug Approval for 2025

Despite a major turmoil and an important number of resignations, the U.S FDA’s Center for Drug Evaluation and Research (CDER) indicates that the health agency has approved 46 “novel” drugs in 2025. "Novel" drugs are new drugs never before approved or marketed in the U.S. The full list of the new drugs, their commercial names and their therapeutic indications can be found through the following link.

https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025

First things first. Out of the 46 approved drugs, 32 are small molecules (SMEs), proving again, and for the last 50 years, that medicinal chemistry is the major contributor to the emergence of new drugs.  

In 2025, CDER approvals were inferior to the ones of 2024 and 2023,  when the U.S FDA had granted respectively 50 and 55 new marketing authorisations.

As in previous years, cancer therapeutics have the largest number of drugs approved with biotechnology and larger companies splitting the 23 approvals in oncology.

Geographic distribution of the various sponsors is also of interest: 22 originated from the US, 15 from Europe, 3 from Japan, 2 from Canada and 2 from China.

Only 20 out of the 46 approvals were granted to large or well-established biopharmaceutical companies, confirming an recent trend where emerging biotechnology companies develop a strategy to file by themselves, in the US, to maximise the value of their assets.

This report will be the last one published under the btobioinnovation platform. We intend to provide future publications under a new format to be announced in early 2026.

Paris, January 3, 2026

This document has been prepared by btobioinnovation and is provided to you for information purposes only.  The information contained in this document has been obtained from sources that btobioinnovation believes are reliable but btobioinnovation does not warrant that it is accurate or complete. The views presented in this document are those of btobioinnovation’s editor at the time of writing and are subject to change.  btobioinnovation has no obligation to update its opinions or the information in this document.

Despite a major turmoil and an important number of resignations, the U.S FDA’s Center for Drug Evaluation and Research (CDER) indicates that the health agency has approved 44 “novel” drugs in 2025. "Novel" drugs are new drugs never before approved or marketed in the U.S. The full list of the new drugs, their commercial names and their therapeutic indications can be found through the following link.

https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025

First things first. Out of the 44 approved drugs, 31 are small molecules (SMEs), proving again, and for the last 50 years, that medicinal chemistry is the major contributor to the emergence of new drugs.  

In 2025, CDER approvals were inferior to the ones of 2024 and 2023,  when the U.S FDA had granted respectively 50 and 55 new marketing authorisations.

As in previous years, cancer therapeutics have the largest number of drugs approved with biotechnology and larger companies splitting the 22 approvals in oncology.

Geographic distribution of the various sponsors is also of interest: 22 originated from the US, 15 from Europe, 3 from Japan, 2 from Canada and 2 from China.

Only 20 out of the 44 approvals were granted to large or well-established biopharmaceutical companies, confirming an recent trend where emerging biotechnology companies develop a strategy to file by themselves, in the US, to maximise the value of their assets.

This report will be the last one published under the btobioinnovation platform. We intend to provide future publications under a new format to be announced in early 2026.

Paris, December 31, 2025

This document has been prepared by btobioinnovation and is provided to you for information purposes only.  The information contained in this document has been obtained from sources that btobioinnovation believes are reliable but btobioinnovation does not warrant that it is accurate or complete. The views presented in this document are those of btobioinnovation’s editor at the time of writing and are subject to change.  btobioinnovation has no obligation to update its opinions or the information in this document.