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sniff results

“PDUFA”

20 total hits · 0 drugs · 0 companies · 0 diseases · 9 catalysts · 11 news

Drugs(0)

expand →
no drug names matched

🐶 Companies(0)

expand →
no companies matched

Catalysts(9)

expand →
Mar 29, 2027
pdufa
in 5mo
Rare Disease PDUFA 2027-03-29
Rare Disease
→
Jan 21, 2027
pdufa
in 3mo
Ultragenyx Pharmaceutical Inc. PDUFA 2027-01-21
Ultragenyx Pharmaceutical Inc.
→
Jan 21, 2027
pdufa
in 3mo
Ultragenyx Pharmaceutical Inc. PDUFA 2027-01-21
Ultragenyx Pharmaceutical Inc.
→
Jan 15, 2027
pdufa
in 3mo
Rare Disease PDUFA 2027-01-15
Rare Disease
→
Sep 10, 2026
pdufa
2mo ago
Ovid Therapeutics Inc. PDUFA 2026-09-10
Ovid Therapeutics Inc.
→
Apr 30, 2026
pdufa
6mo ago
Axsome Therapeutics Inc — (bupropion hydrochloride + dextromethorphan) ER (PDUFA)
(bupropion hydrochloride + dextromethorphan) ER
→
Apr 29, 2026
pdufa
6mo ago
Sanofi — teplizumab (PDUFA)
teplizumab
→
Apr 28, 2026
pdufa
6mo ago
Merck & Co Inc — (doravirine + islatravir hydrate) (PDUFA)
(doravirine + islatravir hydrate)
→
view all 9 catalyst results →

News(11)

expand →
  • Gilead CAR-T on partial clinical hold; Agios' PDUFA date pushed back↗
    Plus news about Acumen, Bristol Myers Squibb, Regeneron, Aer Therapeutics and Hemay Pharmaceutical. Gilead pauses CAR-T after ICANS: After several cases of the neurological condition known as ICANS…
    endpoints · 5h ago
  • New PDUFA deal sets aside FDA money to rehire reviewers↗
    Top pharmaceutical trade groups say the FDA will have a dedicated pool of money to replenish its stable of reviewers as part of the new Prescription Drug User Fee Act (PDUFA) agreement, after HHS l…
    endpoints · 22d ago
  • Graham: PDUFA VIII reflects ‘America First’ principles↗
    Officials from the US Food and Drug Administration (FDA) reaffirmed the administration's priorities in the proposed commitment letter for the Prescription Drug User Fee Act (PDUFA VIII) program dur…
    raps · 1mo ago
  • FDA hears input on psychedelics, PDUFA, lung cancer’s next-gen therapies boost survival↗
The FDA held a public forum on Monday to discuss the future of psychedelic therapeutics, followed by a meeting on Wednesday regarding recommendations for reauthorizing the Prescription Drug User Fe…
biospace · 1mo ago
  • Rare disease reform, CMC risk, reshoring US trials top of mind ahead of PDUFA VIII meeting↗
    The FDA gathers Wednesday to hear what industry stakeholders and the public want included in the latest iteration of the Prescription Drug User Fee Act that sets the agency’s priorities for fiscal…
    biospace · 1mo ago
  • For PDUFA VIII, the most valuable incentive may be time↗
    The FDA’s proposal to offer 50% off application fees for drugs with early-stage trials conducted in the U.S. is unlikely to achieve the intended result. What biotechs really want is speed.
    biospace · 1mo ago
  • FDA delays Capricor's deramiocel PDUFA date to review new data↗
    The 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 · 2mo ago
  • Capricor investor calls for change as company awaits decision on Duchenne candidate↗
    Kaos 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 · 2mo ago
  • view all 11 news results →
    $RARE16.78-2.44%
    $OVID2.5600+4.49%
    $RARE16.78-2.44%
    $AXSM143.45-0.04%
    $RARE16.78-2.44%
    $SNY43.13+2.11%
    $MRK146.33+3.83%