Latest News for: pdufa
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ImmunityBio Announces FDA Acceptance of Supplemental BLA for ANKTIVA® Plus BCG in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer with Papillary Disease; PDUFA Date Set for January 6, 2027
Pharmiweb 20 May 2026
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Leqembi® Iqlik™ PDUFA date updated to August 24 in the U.S.
PR Newswire 08 May 2026
The new Prescription Drug User Fee Act (PDUFA) action date is August 24, 2026. ... https.//news.cision.com/bioarctic/r/leqembi--iqlik--pdufa-date-updated-to-august-24-in-the-u-s-,c4346314.
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Catalyst Monitor: Q2 2026 Outlook Report - Trial Initiations, Completions, Top-line Results, Regulatory Filings, PDUFA ...
Nasdaq Globe Newswire 06 May 2026
Insights into clinical trials for Duchenne muscular dystrophy and obesity present further prospects ... .
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PDUFA creates an efficient drug review process that benefits American patients (PhRMA - Pharmaceutical Research and Manufacturers of America)
Public Technologies 22 Apr 2026
) The Prescription Drug User Fee Act (PDUFA) is essential to maintaining America's leadership in drug development and ensuring patients have timely access to new treatments.
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PolyPid Receives PDUFA Fee Waiver from FDA for D-PLEX₁₀₀’s New Drug Application
Nasdaq Globe Newswire 17 Mar 2026
FDA Grants $4.3 Million Small Business Waiver, Enabling Focus on Commercialization Preparations ... .
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Lantheus Announces Three-Month Extension of PDUFA Date for LNTH-2501 (Ga 68 edotreotide), a PET Diagnostic ...
Nasdaq Globe Newswire 17 Mar 2026
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CAP-1002：Capricor Therapeutics Announces Establishment of New PDUFA Date (Nippon Shinyaku Co Ltd)
Public Technologies 11 Mar 2026
In addition, the FDA has newly set the Prescription Drug User Fee Act date (PDUFA date) for August 22, 2026 (U.S ... review of the application and assigned a PDUFA target action date of August 22, 2026.
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Capricor Therapeutics Announces Establishment of New PDUFA Date for Deramiocel BLA
Nasdaq Globe Newswire 10 Mar 2026
The submission has been classified as a Class 2 resubmission, with a Prescription Drug User Fee Act (“PDUFA”) target action date of ...
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Capricor Therapeutics Announces Establishment of New PDUFA Date for Deramiocel BLA (Form 8-K) (Capricor Therapeutics Inc)
Public Technologies 10 Mar 2026
Capricor Therapeutics Announces Establishment of New PDUFA Date for Deramiocel BLA ● Deramiocel has the potential to become the first therapy to address both skeletal and cardiac manifestations of Duchenne muscular dystrophy.
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