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BioWorld - Saturday, February 21, 2026
Home » Monthly Biopharma Regulatory Analysis

Articles Tagged with ''Monthly Biopharma Regulatory Analysis''

FDA Approved stamp with pills, bottle, blister pack
Biopharma regulatory actions and approvals May 2024

Two Eylea biosimilars among 11 FDA drug approvals in May

June 25, 2024
By Amanda Lanier
In May, the U.S. FDA approved 11 new drugs, a significant drop from the 26 approvals in April, which was the sixth-highest monthly total since 2016. This also falls short of March’s record-setting 30 approvals, the highest number recorded by BioWorld.
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FDA Approved stamp with pills, bottle, blister pack
Biopharma regulatory actions and approvals May 2024

Two Eylea biosimilars among 11 FDA drug approvals in May

June 21, 2024
By Amanda Lanier
In May, the U.S. FDA approved 11 new drugs, a significant drop from the 26 approvals in April, which was the sixth-highest monthly total since 2016. This also falls short of March’s record-setting 30 approvals, the highest number recorded by BioWorld.
Read More
FDA Approved stamp
Biopharma regulatory actions and approvals April 2024

US FDA continues high pace in April with 26 drug approvals

May 17, 2024
By Amanda Lanier
In April, the U.S. FDA approved 26 new drugs, the sixth-highest monthly total going back to 2016. This is slightly lower than March’s record-setting 30 approvals, the highest count in BioWorld’s records. By comparison, the FDA approved an average of about 16 drugs per month in 2023, 12.5 per month in 2022, and 17 per month in both 2021 and 2020.
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FDA approved metal stamp
Biopharma regulatory actions and approvals March 2024

US FDA makes history with 30 drugs approved in March

April 23, 2024
By Amanda Lanier
In March, the U.S. FDA approved 30 new drugs, marking the highest monthly count in BioWorld’s records. The previous highest month of June 2020, with 29 FDA approvals, is followed by November 2017’s 27 approvals.
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FDA approved metal stamp
Biopharma regulatory actions and approvals March 2024

US FDA makes history with 30 drugs approved in March

April 19, 2024
By Amanda Lanier
In March, the U.S. FDA approved 30 new drugs, marking the highest monthly count in BioWorld’s records. The previous highest month of June 2020, with 29 FDA approvals, is followed by November 2017’s 27 approvals. In 2023, the FDA greenlit an average of about 16 drugs per month, 12.5 in 2022, and 17 in both 2021 and 2020. The surge in March marks a 173% increase from the 11 drugs approved in February.
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FDA Approved seal
Biopharma regulatory actions and approvals February 2024

11 US approvals in February include biosimilar, treatments for frostbite, HIV

March 26, 2024
By Amanda Lanier
In February, the U.S. FDA greenlit 11 new drugs, a slight decrease from the 14 approvals seen in the same month the previous year but an increase from January’s tally of eight FDA approvals.
Read More
FDA Approved seal
Biopharma regulatory actions and approvals February 2024

11 US approvals in February include biosimilar, treatments for frostbite, HIV

March 22, 2024
By Amanda Lanier
In February, the U.S. FDA greenlit 11 new drugs, a slight decrease from the 14 approvals seen in the same month the previous year but an increase from January’s tally of eight FDA approvals.
Read More
Approved stamp
Biopharma regulatory actions and approvals January 2024

New year gets a slow start with 8 US FDA approvals in January

Feb. 16, 2024
By Amanda Lanier
The U.S. FDA approved eight drugs in January 2024, down from 10 approvals the previous January and also down from December’s 21 FDA greenlights. Approvals of new molecular entities also continued to decline, going from six in November to three in December, to one in the first month of 2024.
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FDA Approved stamp
Biopharma regulatory actions and approvals December 2023

2023 ends year with 191 US FDA approvals, including 55 NMEs

Jan. 19, 2024
By Amanda Lanier
The U.S. FDA approved 21 drugs in December, bringing the total for the year to 191, a 26% increase to the 151 U.S. approvals in 2022. New molecular entities (NMEs) fell from six in November to three in December, bringing the annual number of NMEs approved to 55.
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FDA Approved stamp
Biopharma regulatory actions and approvals November 2023

FDA nods remain up from last year, yet lag behind 2017-2021

Dec. 22, 2023
By Amanda Lanier
In November, the U.S. FDA approved a total of 12 drugs, a decrease from 27 the previous month that marked the highest number of approvals since June 2020, as reported by BioWorld. From January to November, FDA approvals reached 167, an increase of 21.9% from 137 drugs approved during the same time period the previous year.
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