pdufa.bio
CalendarDecisionsApprovals/yrTrial oddsLearnResearchMethodology
Home › FDA Decisions › Approvals

FDA Approvals Archive

FDA drug approvals with the decision-day move and run-up history; source-linked where verified. Labels under active validation; cross-check filings.
Browse: ✓ Approvals  ·  ✗ Complete Response Letters
2026 · 15
ASND · 2026-02-28 ✓
Approved — price-only
ETON · 2026-02-25 ✓
Approved — price-only
REGN · 2026-02-24 ✓
Approved — price-only
SNY · 2026-02-24 ✓
Approved — price-only
VNDA · 2026-02-21 ✓
Approved — price-only
AZN · 2026-02-20 ✓
Approved — price-only
ABBV · 2026-02-20 ✓
Approved — price-only
MRK · 2026-02-20 ✓
Approved — price-only
JNJ · 2026-02-17 ✓
Approved — price-only
INVA · 2026-02-17 ✓
Approved — price-only
GKOS · 2026-01-28 ✓
Approved — price-only
JNJ · 2026-01-27 ✓
Approved — price-only
GLSI · 2026-01-22 ✓
Approved — price-only
EBS · 2026-01-14 ✓
Approved — price-only
FBIO · 2026-01-13 ✓
Approved — price-only
2025 · 221
VNDA · 2025-12-30 ✓
Approved — price-only
OMER · 2025-12-24 ✓
Approved — price-only
AGIO · 2025-12-23 ✓
Approved — price-only
NVO · 2025-12-22 ✓
Approved — price-only
AMRX · 2025-12-22 ✓
Approved — price-only
RHHBY · 2025-12-22 ✓
Approved — price-only
CYTK · 2025-12-19 ✓
Approved — price-only
PBM · 2025-12-19 ✓
Approved — price-only
COCP · 2025-12-18 ✓
Approved — price-only
JNJ · 2025-12-18 ✓
Approved — price-only
GILD · 2025-12-16 ✓
Approved — price-only
DSNKY · 2025-12-15 ✓
Approved — price-only
MIST · 2025-12-15 ✓
Approved — price-only
JNJ · 2025-12-15 ✓
Approved — price-only
AZN · 2025-12-15 ✓
Approved — price-only
INVA · 2025-12-15 ✓
Approved — price-only
AMPH · 2025-12-15 ✓
Approved — price-only
ACAD · 2025-12-12 ✓
Approved — price-only
BCRX · 2025-12-12 ✓
Approved — price-only
AMGN · 2025-12-11 ✓
Approved — price-only
GSK · 2025-12-11 ✓
Approved — price-only
AXGN · 2025-12-04 ✓
Approved — price-only
BMY · 2025-12-04 ✓
Approved — price-only
LLY · 2025-12-03 ✓
Approved — price-only
AMRN · 2025-12-02 ✓
Approved — price-only
AMRX · 2025-12-01 ✓
Approved — price-only
JANX · 2025-12-01 ✓
Approved — price-only
AZN · 2025-11-25 ✓
Approved — price-only
SRPT · 2025-11-25 ✓
Approved — price-only
RHHBY · 2025-11-25 ✓
Approved — price-only
NVS · 2025-11-24 ✓
Approved — price-only
MRK · 2025-11-21 ✓
Approved — price-only
ALPMY · 2025-11-21 ✓
Approved — price-only
PFE · 2025-11-21 ✓
Approved — price-only
BAYRY · 2025-11-20 ✓
Approved — price-only
AZN · 2025-11-20 ✓
Approved — price-only
AMGN · 2025-11-19 ✓
Approved — price-only
REGN · 2025-11-19 ✓
Approved — price-only
ARWR · 2025-11-18 ✓
Approved — price-only
GMAB · 2025-11-18 ✓
Approved — price-only
ABBV · 2025-11-18 ✓
Approved — price-only
OGN · 2025-11-17 ✓
Approved — price-only
KURA · 2025-11-13 ✓
Approved — price-only
AMRX · 2025-11-13 ✓
Approved — price-only
JNJ · 2025-11-07 ✓
Approved — price-only
BCAB · 2025-11-07 ✓
Approved — price-only
JNJ · 2025-11-06 ✓
Approved — price-only
AGIO · 2025-11-03 ✓
Approved — price-only
AMRX · 2025-10-29 ✓
Approved — price-only
ONCY · 2025-10-28 ✓
Approved — price-only
LLY · 2025-10-27 ✓
Approved — price-only
MRK · 2025-10-27 ✓
Approved — price-only
SNDX · 2025-10-24 ✓
Approved — price-only
BAYRY · 2025-10-24 ✓
Approved — price-only
GSK · 2025-10-23 ✓
Approved — price-only
GKOS · 2025-10-20 ✓
Approved — price-only
RHHBY · 2025-10-20 ✓
Approved — price-only
AZN · 2025-10-17 ✓
Approved — price-only
AMGN · 2025-10-17 ✓
Approved — price-only
NVO · 2025-10-15 ✓
Approved — price-only
ABBV · 2025-10-13 ✓
Approved — price-only
TEVA · 2025-10-10 ✓
Approved — price-only
REGN · 2025-10-08 ✓
Approved — price-only
ARQT · 2025-10-06 ✓
Approved — price-only
RHHBY · 2025-10-02 ✓
Approved — price-only
JAZZ · 2025-10-02 ✓
Approved — price-only
NVS · 2025-09-30 ✓
Approved — price-only
JNJ · 2025-09-29 ✓
Approved — price-only
LLY · 2025-09-25 ✓
Approved — price-only
CRNX · 2025-09-25 ✓
Approved — price-only
AMRX · 2025-09-23 ✓
Approved — price-only
INCY · 2025-09-19 ✓
Approved — price-only
MRK · 2025-09-19 ✓
Approved — price-only
JNJ · 2025-09-19 ✓
Approved — price-only
KRYS · 2025-09-15 ✓
Approved — price-only
AMRX · 2025-09-11 ✓
Approved — price-only
JNJ · 2025-09-09 ✓
Approved — price-only
TAK · 2025-09-05 ✓
Approved — price-only
AMRX · 2025-09-04 ✓
Approved — price-only
SNY · 2025-08-29 ✓
Approved — price-only
BIIB · 2025-08-29 ✓
Approved — price-only
TEVA · 2025-08-28 ✓
Approved — price-only
LGND · 2025-08-27 ✓
Approved — price-only
BNTX · 2025-08-27 ✓
Approved — price-only
MRNA · 2025-08-27 ✓
Approved — price-only
TVTX · 2025-08-27 ✓
Approved — price-only
NVAX · 2025-08-27 ✓
Approved — price-only
PRTA · 2025-08-27 ✓
Approved — price-only
PFE · 2025-08-27 ✓
Approved — price-only
VALN · 2025-08-25 ✓
Approved — price-only
IONI · 2025-08-21 ✓
Approved — price-only
IONS · 2025-08-21 ✓
Approved — price-only
PGEN · 2025-08-15 ✓
Approved — price-only
NVO · 2025-08-15 ✓
Approved — price-only
TNXP · 2025-08-15 ✓
Approved — price-only
INSM · 2025-08-12 ✓
Approved — price-only
PHRRF · 2025-08-11 ✓
Approved — price-only
AMPH · 2025-08-11 ✓
Approved — price-only
TEVA · 2025-08-06 ✓
Approved — price-only
JAZZ · 2025-08-06 ✓
Approved — price-only
LENZ · 2025-07-31 ✓
Approved — price-only
ANIK · 2025-07-30 ✓
Approved — price-only
ASND · 2025-07-28 ✓
Approved — price-only
PTCT · 2025-07-28 ✓
Approved — price-only
APLS · 2025-07-28 ✓
Approved — price-only
GSK · 2025-07-17 ✓
Approved — price-only
KALV · 2025-07-07 ✓
Approved — price-only
CMND · 2025-07-03 ✓
Approved — price-only
REGN · 2025-07-02 ✓
Approved — price-only
EXEL · 2025-07-02 ✓
Approved — price-only
ABBV · 2025-06-30 ✓
Approved — price-only
TAK · 2025-06-30 ✓
Approved — price-only
BMY · 2025-06-27 ✓
Approved — price-only
GSK · 2025-06-24 ✓
Approved — price-only
AVBP · 2025-06-23 ✓
Approved — price-only
AZN · 2025-06-23 ✓
Approved — price-only
DSNKY · 2025-06-23 ✓
Approved — price-only
GILD · 2025-06-18 ✓
Approved — price-only
NVS · 2025-06-18 ✓
Approved — price-only
XNCR · 2025-06-18 ✓
Approved — price-only
INCY · 2025-06-18 ✓
Approved — price-only
CSLLY · 2025-06-17 ✓
Approved — price-only
HOTH · 2025-06-16 ✓
Approved — price-only
MRK · 2025-06-13 ✓
Approved — price-only
AMRX · 2025-06-12 ✓
Approved — price-only
MRNA · 2025-06-12 ✓
Approved — price-only
URGN · 2025-06-12 ✓
Approved — price-only
NUVB · 2025-06-11 ✓
Approved — price-only
ABBV · 2025-06-11 ✓
Approved — price-only
ENTA · 2025-06-11 ✓
Approved — price-only
MRK · 2025-06-09 ✓
Approved — price-only
REGN · 2025-06-02 ✓
Approved — price-only
SNY · 2025-06-02 ✓
Approved — price-only
MRNA · 2025-05-31 ✓
Approved — price-only
ETON · 2025-05-29 ✓
Approved — price-only
ALC · 2025-05-28 ✓
Approved — price-only
BCTX · 2025-05-23 ✓
Approved — price-only
LQDA · 2025-05-23 ✓
Approved — price-only
RHHBY · 2025-05-22 ✓
Approved — price-only
ARQT · 2025-05-22 ✓
Approved — price-only
GSK · 2025-05-22 ✓
Approved — price-only
NVAX · 2025-05-19 ✓
Approved — price-only
AMRX · 2025-05-15 ✓
Approved — price-only
INCY · 2025-05-15 ✓
Approved — price-only
MRK · 2025-05-14 ✓
Approved — price-only
ABBV · 2025-05-14 ✓
Approved — price-only
CING · 2025-05-14 ✓
Approved — price-only
OGEN · 2025-05-13 ✓
Approved — price-only
VSTM · 2025-05-08 ✓
Approved — price-only
TEVA · 2025-05-05 ✓
Approved — price-only
ALVO · 2025-05-05 ✓
Approved — price-only
JNJ · 2025-04-30 ✓
Approved — price-only
XRTX · 2025-04-30 ✓
Approved — price-only
ABEO · 2025-04-29 ✓
Approved — price-only
ABBV · 2025-04-29 ✓
Approved — price-only
EQ · 2025-04-24 ✓
Approved — price-only
ANTE · 2025-04-23 ✓
Approved — price-only
REGN · 2025-04-18 ✓
Approved — price-only
SNY · 2025-04-18 ✓
Approved — price-only
MIRM · 2025-04-14 ✓
Approved — price-only
IRWD · 2025-04-14 ✓
Approved — price-only
BMY · 2025-04-11 ✓
Approved — price-only
HALO · 2025-04-10 ✓
Approved — price-only
ARGX · 2025-04-10 ✓
Approved — price-only
BMY · 2025-04-08 ✓
Approved — price-only
AMGN · 2025-04-03 ✓
Approved — price-only
NVS · 2025-04-03 ✓
Approved — price-only
ABBV · 2025-04-02 ✓
Approved — price-only
AZN · 2025-03-31 ✓
Approved — price-only
ALNY · 2025-03-28 ✓
Approved — price-only
INTE · 2025-03-28 ✓
Approved — price-only
SNY · 2025-03-28 ✓
Approved — price-only
NVS · 2025-03-28 ✓
Approved — price-only
SLNO · 2025-03-26 ✓
Approved — price-only
WVE · 2025-03-26 ✓
Approved — price-only
IPSEY · 2025-03-26 ✓
Approved — price-only
EXEL · 2025-03-26 ✓
Approved — price-only
GSK · 2025-03-25 ✓
Approved — price-only
CNTA · 2025-03-24 ✓
Approved — price-only
TLX · 2025-03-21 ✓
Approved — price-only
NVS · 2025-03-20 ✓
Approved — price-only
ALNY · 2025-03-20 ✓
Approved — price-only
JNJ · 2025-03-20 ✓
Approved — price-only
XERS · 2025-03-17 ✓
Approved — price-only
GLSI · 2025-03-17 ✓
Approved — price-only
ANIP · 2025-03-14 ✓
Approved — price-only
RNAZ · 2025-03-13 ✓
Approved — price-only
SPRY · 2025-03-05 ✓
Approved — price-only
RHHBY · 2025-03-03 ✓
Approved — price-only
INDV · 2025-02-24 ✓
Approved — price-only
MIRM · 2025-02-24 ✓
Approved — price-only
APTO · 2025-02-20 ✓
Approved — price-only
IBRX · 2025-02-19 ✓
Approved — price-only
GSK · 2025-02-17 ✓
Approved — price-only
TURN · 2025-02-14 ✓
Approved — price-only
ALPMY · 2025-02-13 ✓
Approved — price-only
PFE · 2025-02-12 ✓
Approved — price-only
RHHBY · 2025-02-12 ✓
Approved — price-only
SWTX · 2025-02-11 ✓
Approved — price-only
ABBV · 2025-02-07 ✓
Approved — price-only
RNAZ · 2025-02-06 ✓
Approved — price-only
SUPN · 2025-02-04 ✓
Approved — price-only
RHHBY · 2025-02-04 ✓
Approved — price-only
VRTX · 2025-01-30 ✓
Approved — price-only
AXSM · 2025-01-30 ✓
Approved — price-only
NVS · 2025-01-29 ✓
Approved — price-only
NVO · 2025-01-28 ✓
Approved — price-only
DSNKY · 2025-01-27 ✓
Approved — price-only
AZN · 2025-01-27 ✓
Approved — price-only
BIIB · 2025-01-26 ✓
Approved — price-only
AMRX · 2025-01-23 ✓
Approved — price-only
IRON · 2025-01-21 ✓
Approved — price-only
JNJ · 2025-01-21 ✓
Approved — price-only
AZN · 2025-01-17 ✓
Approved — price-only
AMGN · 2025-01-17 ✓
Approved — price-only
INCY · 2025-01-16 ✓
Approved — price-only
SNDX · 2025-01-16 ✓
Approved — price-only
LEXX · 2025-01-15 ✓
Approved — price-only
LLY · 2025-01-15 ✓
Approved — price-only
KZIA · 2025-01-02 ✓
Approved — price-only
ANIP · 2025-01-02 ✓
Approved — price-only