United States — Center for Drug Evaluation and Research
Tracked across 7 events · 47 articles · First seen Jun 12, 2026 · Last active Aug 24, 2026
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Regulatory
Impact: The CDE is the specific agency that granted the BTD, playing a key role in the regulatory process. Its decision is crucial for the accelerated development of the combination therapy.
Aug 03, 2026 · 6 articles
Regulatory
On August 24, 2026, Paragon Therapeutics announced that the U.S. United States — Food and Drug Administration (FDA) extended the PDUFA target action date for its Biologics License Application (BLA) for Deramiocel, an investigational cell…
Impact: CBER accepted the amendment for review and classified it as major, necessitating the extended review period.
Aug 24, 2026 · 7 articles
Business
Impact: The United States — Center for Drug Evaluation and Research provided positive pre-submission regulatory feedback for NCX 470, which is crucial for the drug's approval process in China.
Jun 18, 2026 · 7 articles
Regulatory
Impact: CBER, the FDA center responsible for the review, granted the supplemental approval and utilized expedited review programs.
Jul 01, 2026 · 6 articles
Business
Impact: The United States — Center for Drug Evaluation and Research accepted a supplemental New Drug Application for Gumokimab in active ankylosing spondylitis, indicating potential future market expansion for the drug.
Jun 12, 2026 · 7 articles
Tech
Impact: The CDE, as part of NMPA, approved the IND application, playing a regulatory role in the event.
Jul 27, 2026 · 6 articles
Business
Impact: China's CDE received sNDA for first-line Zegfrovy and granted Breakthrough Therapy Designation.
Jul 14, 2026 · 8 articles
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