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BioWorld - Monday, April 6, 2026
Home » Topics » Regulatory » NME

NME
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NME Digest: Q4 2025

Feb. 13, 2026
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A quarterly dynamic table featuring new molecular entities (NMEs) revealed for the first time in current literature, at congresses and in company communications during the quarter.
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FDA Approved seal
Biopharma regulatory actions and approvals October 2025

Jascayd for idiopathic pulmonary fibrosis among 20 October US nods

Nov. 21, 2025
By Amanda Lanier
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The U.S. FDA cleared 20 drugs in October 2025, up from 17 in September, 18 in August and 17 in July, bringing the year’s total to 181 approvals through the first 10 months. Two new molecular entities (NMEs) gained U.S. approval in October: Boehringer Ingelheim GmbH’s Jascayd and Bayer AG’s Lynkuet.
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NME Digest: Q3 2025

Nov. 4, 2025
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A quarterly dynamic table featuring new molecular entities (NMEs) revealed for the first time in current literature, at congresses and in company communications during the quarter.
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FDA Approved stamp with pills, bottle, blister pack
Biopharma regulatory actions and approvals August 2025

US FDA adds five NMEs in August, led by Brinsupri and Modeyso

Sep. 19, 2025
By Amanda Lanier
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The U.S. FDA cleared 18 drugs in August, comparable to July’s 17 but down from June’s 23 approvals. That brings the 2025 U.S. total through August to 143, matching 2020 as the second-highest count on record for BioWorld for the period, after 2024’s high of 159.
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Biopharma regulatory actions and approvals July 2025

US FDA approves six NMEs in July; Kalvista, PTC, Regeneron rise

Aug. 26, 2025
By Amanda Lanier
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The U.S. FDA approved 17 drugs in July, down from 23 in June, bringing the year-to-date total to 125. Through July, 2025 remains the third-highest count in BioWorld’s records, trailing 135 approvals in 2024 and 126 in 2020.
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Biopharma regulatory actions and approvals July 2025

US FDA approves six NMEs in July; Kalvista, PTC, Regeneron rise

Aug. 22, 2025
By Amanda Lanier
No Comments
The U.S. FDA approved 17 drugs in July, down from 23 in June, bringing the year-to-date total to 125. Through July, 2025 remains the third-highest count in BioWorld’s records, trailing 135 approvals in 2024 and 126 in 2020.
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NME Digest: Q2 2025

Aug. 4, 2025
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A quarterly dynamic table featuring new molecular entities (NMEs) revealed for the first time in current literature, at congresses and in company communications during the quarter. You must be a BioWorld Premium subscriber to access this new feature. Contact us to upgrade your account.
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NME Digest: Q2 2025

Aug. 4, 2025
No Comments
A quarterly dynamic table featuring new molecular entities (NMEs) revealed for the first time in current literature, at congresses and in company communications during the quarter. NMEs include compounds chosen for further pharmacological evaluation or as clinical candidates; new leads whose structural optimization could provide new therapeutic agents; new additions to the structural diversity of known mechanistic classes of drugs; and new pharmacological tools for investigating drug targets.
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Investigation into questionable investments prompts executive re-shuffle at China’s Cstone

June 7, 2022
By Tamra Sami
Cstone Pharmaceuticals Co. Ltd. has begun trading again on the Hong Kong exchange after trading was halted on April 1 following investigations over questionable investments during the company’s year-end audit for 2021.
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Investigation into questionable investments prompts executive re-shuffle at China’s Cstone

June 2, 2022
By Tamra Sami
Suzhou, China-based Cstone Pharmaceuticals Co. Ltd. has begun trading again on the Hong Kong exchange (HKEX:02616) after trading was halted on April 1 following investigations over questionable investments during the company’s year-end audit for 2021.
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