Latest News for: pdufa
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Thalassemia AQVESME PDUFA FINAL (Agios Pharmaceuticals Inc)
Public Technologies 24 Dec 2025
). AQVESME (mitapivat) FDA Approval. Conference call for investors and analysts 23 December 2025. Agenda - AQVESME (mitapivat) FDA Approval Introduction Morgan Sanford, VP Investor Relations. CEO Opening Remarks Brian Goff, Chief Executive Officer ... 3 ... 4 ... 1.
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Aldeyra Therapeutics Announces PDUFA Extension of the New Drug Application of Reproxalap for the Treatment ...
Business Wire 16 Dec 2025
The extended PDUFA target action date is March 16, 2026.
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Aldeyra Therapeutics Announces PDUFA Extension of the New Drug Application of Reproxalap for the Treatment of Dry Eye Disease (Form 8-K) (Aldeyra Therapeutics Inc)
Public Technologies 16 Dec 2025
Aldeyra Therapeutics Announces PDUFA Extension of the New Drug Application of Reproxalap for the Treatment of Dry Eye Disease ... The extended PDUFA target action date is March 16, 2026 ... PDUFA extension.
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Aldeyra Therapeutics Announces PDUFA Extension of the New Drug Application of Reproxalap for the Treatment of Dry Eye Disease
Pharmiweb 16 Dec 2025
Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for the reproxalap New Drug Application (NDA) for the treatment of dry eye disease. The extended PDUFA target action date is March 16, 2026.
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ITM Announces FDA Acceptance of New Drug Application (NDA) and PDUFA Date for n.c.a. 177Lu-edotreotide ...
Nasdaq Globe Newswire 13 Nov 2025
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Caledonian Record
13 Nov 2025
ITM Announces FDA Acceptance of New Drug Application (NDA) and PDUFA Date for n.c.a.
Prescription Drug User Fee Act (PDUFA) goal date set for August 28, 2026 ....
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Enid News & Eagle
30 Oct 2025
Lantheus Announces FDA Grants PDUFA Date for LNTH-2501 (Ga 68 edotreotide), a PET Diagnostic
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Xspray Pharma: FDA accepts New Drug Application for XS003 (nilotinib) for the treatment of CML - PDUFA date set for June 18, 2026 (XSpray Pharma AB (publ))
Public Technologies 21 Oct 2025
FDA accepts New Drug Application for XS003 (nilotinib) for the treatment of CML - PDUFA date set for June 18, 2026 ... The FDA has set a PDUFA date to June 18, 2026, which is the date by when the agency ...
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FDA Accepts Cingulate’s New Drug Application for CTx-1301 in Attention-Deficit/Hyperactivity Disorder (ADHD) and sets a May 31, 2026 PDUFA Date (Form 8-K) (Cingulate Inc)
Public Technologies 14 Oct 2025
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026.
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