sniff results
“PDUFA”
12 total hits · 0 drugs · 0 companies · 0 diseases · 7 catalysts · 5 news
Drugs(0)
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no drug names matched
🐶 Companies(0)
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no companies matched
Catalysts(7)
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Jan 21, 2027
pdufa
PDUFA — 2027-01-21
Ultragenyx Pharmaceutical Inc.
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Jan 4, 2027
pdufa
PDUFA — 2027-01-04
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Jul 17, 2026
pdufa
PDUFA — 2026-07-17
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Apr 30, 2026
pdufa
Axsome Therapeutics Inc — (bupropion hydrochloride + dextromethorphan) ER (PDUFA)
(bupropion hydrochloride + dextromethorphan) ER
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Apr 29, 2026
pdufa
Sanofi — teplizumab (PDUFA)
teplizumab
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Apr 28, 2026
pdufa
Merck & Co Inc — (doravirine + islatravir hydrate) (PDUFA)
(doravirine + islatravir hydrate)
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Apr 27, 2026
pdufa
Regeneron Pharmaceuticals Inc — dupilumab (PDUFA)
dupilumab
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News(5)
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- FDA delays Capricor's deramiocel PDUFA date to review new dataThe FDA is pushing back its decision on Capricor Therapeutics’ problematic Duchenne muscular dystrophy therapy to review additional data for a more niche indication. The company on Monday said the…endpoints · 13d ago
- Capricor investor calls for change as company awaits decision on Duchenne candidateKaos Capital in a letter to other Capricor Therapeutics shareholders called for “an immediate meeting, board change, and capital-preservation plan.” The biotech recently put all other pipeline work…biospace · 16d ago
- PDUFA VIII commitments: 'America First' provisions, faster reviews and moreThe FDA's next five-year reauthorization of the prescription drug user fee program will feature new incentives for domestic pharma companies, newly sped up reviews for some applications, and improv…endpoints · 24d ago
- PDUFA VIII: FDA outlines goals, program enhancements in commitment letter