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FDA Tracker @fda_tracker

Analytics for Pharma and Biotech Traders

Joined October 2011
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$VRTX New PDUFA Date 2026-11-30 VERTEX PHARMACEUTICALS INCORPORATED Link:businesswire.com/news/home/2… Calendar:fdatracker.com/fda-calendar/

Vertex Announces US FDA Acceptance of Biologics License Application for Accelerated Approval of...

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application...

businesswire.com
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$BMY New PDUFA Date 2026-09-30 BRISTOL MYERS SQUIBB Link:businesswire.com/news/home/2… Calendar:fdatracker.com/fda-calendar/

U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Supplemental...

US FDA Accepts for Priority Review Bristol Myers Squibb’s Supplemental New Drug Application for Camzyos to Treat Adolescents with oHCM

businesswire.com
327
$REGMF Phase 3 trial w/est Jun completion date NCT05885503: clinicaltrials.gov/study/NCT… Trial Tracker: fdatracker.com/trial-tracker…
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$ALKS Phase 2 trial w/est Jun completion date NCT06843590: clinicaltrials.gov/study/NCT… Trial Tracker: fdatracker.com/trial-tracker…
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$SNY New PDUFA Date 2026-11-25 Sanofi Winthrop Industrie Link:globenewswire.com/news-relea… Calendar:fdatracker.com/fda-calendar/

Press Release: Sanofi’s venglustat accepted for priority review in the US to treat type 3 Gaucher...

Sanofi’s venglustat accepted for priority review in the US to treat type 3 Gaucher disease Paris, May 28, 2026. The US Food and Drug Administration (FDA)...

globenewswire.com
285
$COGT New PDUFA Date 2026-11-30 Cogent Biosciences, Inc. Link:globenewswire.com/news-relea… Calendar:fdatracker.com/fda-calendar/

Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) with Priority Review for...

NDA acceptance with Priority Review builds upon previous assignment of Breakthrough Therapy Designation and Real-Time Oncology Review following Phase 3...

globenewswire.com
415
$BBIO New PDUFA Date 2026-11-27 BridgeBio Pharma, Inc. Link:sec.gov/Archives/edgar/data/… Calendar:fdatracker.com/fda-calendar/
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$NUVL New PDUFA Date 2026-11-27 Nuvalent, Inc. Link:prnewswire.com/news-releases… Calendar:fdatracker.com/fda-calendar/

Nuvalent Announces Key Program and Business Updates, Strengthening Foundation for Global Leadership...

/PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically...

prnewswire.com
614
$OPHLY Phase 3 trial w/est May completion date NCT05144854: clinicaltrials.gov/study/NCT… Trial Tracker: fdatracker.com/trial-tracker…
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$NMRA Phase 3 trial w/est May completion date NCT06058039: clinicaltrials.gov/study/NCT… Trial Tracker: fdatracker.com/trial-tracker…
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$NMRA Phase 3 trial w/est May completion date NCT06058013: clinicaltrials.gov/study/NCT… Trial Tracker: fdatracker.com/trial-tracker…
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$MEDD Phase 2 trial w/est May completion date NCT05820724: clinicaltrials.gov/study/NCT… Trial Tracker: fdatracker.com/trial-tracker…
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$LNTH Phase 2 trial w/est May completion date NCT05820724: clinicaltrials.gov/study/NCT… Trial Tracker: fdatracker.com/trial-tracker…
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$IBRX New PDUFA Date 2027-01-06 IMMUNITYBIO, INC. Link:businesswire.com/news/home/2… Calendar:fdatracker.com/fda-calendar/

ImmunityBio Announces FDA Acceptance of Supplemental BLA for ANKTIVA® Plus BCG in BCG-Unresponsive...

ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced that the U.S. Food and Drug Administration has accepted for revie...

businesswire.com
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$INCPF Phase 2 trial w/est May completion date NCT05678270: clinicaltrials.gov/study/NCT… Trial Tracker: fdatracker.com/trial-tracker…
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$INCPF Phase 3 trial w/est May completion date NCT06842199: clinicaltrials.gov/study/NCT… Trial Tracker: fdatracker.com/trial-tracker…
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$VTRS New PDUFA Date 2026-12-27 Viatris Inc. Link:prnewswire.com/news-releases… Calendar:fdatracker.com/fda-calendar/

U.S. FDA Accepts Viatris New Drug Application for Fast-Acting Meloxicam for the Treatment of...

/PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for...

prnewswire.com
373
$GRFS Phase 3 trial w/est May completion date NCT05645107: clinicaltrials.gov/study/NCT… Trial Tracker: fdatracker.com/trial-tracker…
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$EVMN Phase 2 trial w/est May completion date NCT06873516: clinicaltrials.gov/study/NCT… Trial Tracker: fdatracker.com/trial-tracker…
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$ESAIY Phase 2 trial w/est May completion date NCT02780310: clinicaltrials.gov/study/NCT… Trial Tracker: fdatracker.com/trial-tracker…
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