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2025 FDA decisions

Updated ยทnext FDA decision on the calendar

This page lists all 316 FDA decisions from 2025 in our archive: 221 approvals and 95 Complete Response Letters. Every decision links its own page with the source document and the share-price reaction we measured.

January 2025

ANIP · 2025-01-02 ✓ Approvedprice-onlyKZIA · 2025-01-02 ✓ Approvedprice-onlyJSPR · 2025-01-08 CRLsource-verifiedPHIO · 2025-01-13 CRLsource-verifiedLEXX · 2025-01-15 ✓ Approvedprice-onlyLLY · 2025-01-15 ✓ Approvedprice-onlyATRA · 2025-01-16 CRLsource-verifiedINCY · 2025-01-16 ✓ Approvedprice-onlySNDX · 2025-01-16 ✓ Approvedprice-onlyAMGN · 2025-01-17 ✓ Approvedprice-onlyAZN · 2025-01-17 ✓ Approvedprice-onlyINBX · 2025-01-21 CRLprice-onlyIRON · 2025-01-21 ✓ Approvedprice-onlyJNJ · 2025-01-21 ✓ Approvedprice-onlyCHRS · 2025-01-22 CRLprice-onlyLSTA · 2025-01-22 CRLsource-verifiedAMRX · 2025-01-23 ✓ Approvedprice-onlyBIIB · 2025-01-26 ✓ Approvedprice-onlyAZN · 2025-01-27 ✓ Approvedprice-onlyDSNKY · 2025-01-27 ✓ Approvedprice-onlyNVO · 2025-01-28 ✓ Approvedprice-onlyNVS · 2025-01-29 ✓ Approvedprice-onlyAXSM · 2025-01-30 ✓ Approvedprice-onlyVRTX · 2025-01-30 ✓ Approvedprice-only

February 2025

RHHBY · 2025-02-04 ✓ Approvedprice-onlySUPN · 2025-02-04 ✓ Approvedprice-onlyRNAZ · 2025-02-06 ✓ Approvedprice-onlyABBV · 2025-02-07 ✓ Approvedprice-onlySWTX · 2025-02-11 ✓ Approvedprice-onlyPFE · 2025-02-12 ✓ Approvedprice-onlyRHHBY · 2025-02-12 ✓ Approvedprice-onlyALPMY · 2025-02-13 ✓ Approvedprice-onlyALLO · 2025-02-14 CRLsource-verifiedCLLS · 2025-02-14 CRLprice-onlyTURN · 2025-02-14 ✓ Approvedprice-onlyGSK · 2025-02-17 ✓ Approvedprice-onlyHRMY · 2025-02-19 CRLprice-onlyIBRX · 2025-02-19 ✓ Approvedprice-onlyAPTO · 2025-02-20 ✓ Approvedprice-onlyINDV · 2025-02-24 ✓ Approvedprice-onlyMIRM · 2025-02-24 ✓ Approvedprice-only

March 2025

RHHBY · 2025-03-03 ✓ Approvedprice-onlySPRY · 2025-03-05 ✓ Approvedprice-onlyPHIO · 2025-03-10 CRLprice-onlyRNAZ · 2025-03-13 ✓ Approvedprice-onlyANIP · 2025-03-14 ✓ Approvedprice-onlyGLSI · 2025-03-17 ✓ Approvedprice-onlyXERS · 2025-03-17 ✓ Approvedprice-onlyALNY · 2025-03-20 ✓ Approvedprice-onlyJNJ · 2025-03-20 ✓ Approvedprice-onlyNVS · 2025-03-20 ✓ Approvedprice-onlyTLX · 2025-03-21 ✓ Approvedprice-onlyAURA · 2025-03-24 CRLprice-onlyCGON · 2025-03-24 CRLprice-onlyCNTA · 2025-03-24 ✓ Approvedprice-onlyGSK · 2025-03-25 ✓ Approvedprice-onlyEXEL · 2025-03-26 ✓ Approvedprice-onlyIPSEY · 2025-03-26 ✓ Approvedprice-onlySLNO · 2025-03-26 ✓ Approvedprice-onlyWVE · 2025-03-26 ✓ Approvedprice-onlyEQ · 2025-03-27 CRLsource-verifiedALNY · 2025-03-28 ✓ Approvedprice-onlyINTE · 2025-03-28 ✓ Approvedprice-onlyMIST · 2025-03-28 CRLsource-verifiedNVS · 2025-03-28 ✓ Approvedprice-onlySNY · 2025-03-28 ✓ Approvedprice-onlyAZN · 2025-03-31 ✓ Approvedprice-only

April 2025

CMPX · 2025-04-01 CRLprice-onlyABBV · 2025-04-02 ✓ Approvedprice-onlyALDX · 2025-04-03 CRLsource-verifiedAMGN · 2025-04-03 ✓ Approvedprice-onlyNVS · 2025-04-03 ✓ Approvedprice-onlyBMY · 2025-04-08 ✓ Approvedprice-onlyARGX · 2025-04-10 ✓ Approvedprice-onlyHALO · 2025-04-10 ✓ Approvedprice-onlyBMY · 2025-04-11 ✓ Approvedprice-onlyIRWD · 2025-04-14 ✓ Approvedprice-onlyMIRM · 2025-04-14 ✓ Approvedprice-onlyREGN · 2025-04-18 ✓ Approvedprice-onlySNY · 2025-04-18 ✓ Approvedprice-onlyREGN · 2025-04-20 CRLprice-onlyANTE · 2025-04-23 ✓ Approvedprice-onlyEQ · 2025-04-24 ✓ Approvedprice-onlyJNJ · 2025-04-24 CRLprice-onlyALXO · 2025-04-25 CRLprice-onlyTARA · 2025-04-26 CRLprice-onlyURGN · 2025-04-27 CRLprice-onlyCLDI · 2025-04-28 CRLprice-onlyTLX · 2025-04-28 CRLprice-onlyABBV · 2025-04-29 ✓ Approvedprice-onlyABEO · 2025-04-29 ✓ Approvedprice-onlyJNJ · 2025-04-30 ✓ Approvedprice-onlyXRTX · 2025-04-30 ✓ Approvedprice-only

May 2025

ALVO · 2025-05-05 ✓ Approvedprice-onlyTEVA · 2025-05-05 ✓ Approvedprice-onlyPHIO · 2025-05-07 CRLprice-onlyVSTM · 2025-05-08 ✓ Approvedprice-onlyOGEN · 2025-05-13 ✓ Approvedprice-onlyABBV · 2025-05-14 ✓ Approvedprice-onlyCING · 2025-05-14 ✓ Approvedprice-onlyMRK · 2025-05-14 ✓ Approvedprice-onlyAMRX · 2025-05-15 ✓ Approvedprice-onlyINCY · 2025-05-15 ✓ Approvedprice-onlyNVAX · 2025-05-19 ✓ Approvedprice-onlyARQT · 2025-05-22 ✓ Approvedprice-onlyGSK · 2025-05-22 ✓ Approvedprice-onlyRHHBY · 2025-05-22 ✓ Approvedprice-onlyBCTX · 2025-05-23 ✓ Approvedprice-onlyBMY · 2025-05-23 CRLprice-onlyLQDA · 2025-05-23 ✓ Approvedprice-onlyREGN · 2025-05-23 CRLprice-onlySVRA · 2025-05-27 CRLsource-verifiedALC · 2025-05-28 ✓ Approvedprice-onlyETON · 2025-05-29 ✓ Approvedprice-onlyMRNA · 2025-05-31 ✓ Approvedprice-only

June 2025

GMAB · 2025-06-02 CRLprice-onlyREGN · 2025-06-02 ✓ Approvedprice-onlySNY · 2025-06-02 ✓ Approvedprice-onlyIMMX · 2025-06-03 CRLprice-onlyTRAW · 2025-06-03 CRLsource-verifiedAXSM · 2025-06-09 CRLprice-onlyMRK · 2025-06-09 ✓ Approvedprice-onlyABBV · 2025-06-11 ✓ Approvedprice-onlyENTA · 2025-06-11 ✓ Approvedprice-onlyNUVB · 2025-06-11 ✓ Approvedprice-onlyADCT · 2025-06-12 CRLprice-onlyAMRX · 2025-06-12 ✓ Approvedprice-onlyBMY · 2025-06-12 CRLprice-onlyMRNA · 2025-06-12 ✓ Approvedprice-onlyNRIX · 2025-06-12 CRLprice-onlyURGN · 2025-06-12 ✓ Approvedprice-onlyJNJ · 2025-06-13 CRLprice-onlyMRK · 2025-06-13 ✓ Approvedprice-onlyGMAB · 2025-06-15 CRLprice-onlyINCY · 2025-06-15 CRLprice-onlyHOTH · 2025-06-16 ✓ Approvedprice-onlyJSPR · 2025-06-16 CRLprice-onlyLTRN · 2025-06-16 CRLprice-onlyCSLLY · 2025-06-17 ✓ Approvedprice-onlyLYEL · 2025-06-17 CRLprice-onlyGILD · 2025-06-18 ✓ Approvedprice-onlyINCY · 2025-06-18 ✓ Approvedprice-onlyNVS · 2025-06-18 ✓ Approvedprice-onlyXNCR · 2025-06-18 ✓ Approvedprice-onlyGLPG · 2025-06-19 CRLprice-onlyGHRS · 2025-06-20 CRLprice-onlyAVBP · 2025-06-23 ✓ Approvedprice-onlyAZN · 2025-06-23 ✓ Approvedprice-onlyDSNKY · 2025-06-23 ✓ Approvedprice-onlyGSK · 2025-06-24 ✓ Approvedprice-onlyBMY · 2025-06-27 ✓ Approvedprice-onlyABBV · 2025-06-30 ✓ Approvedprice-onlyINTS · 2025-06-30 CRLprice-onlyTAK · 2025-06-30 ✓ Approvedprice-onlyUNCY · 2025-06-30 CRLsource-verified

July 2025

EXEL · 2025-07-02 ✓ Approvedprice-onlyREGN · 2025-07-02 ✓ Approvedprice-onlyCMND · 2025-07-03 ✓ Approvedprice-onlyJSPR · 2025-07-07 CRLsource-verifiedKALV · 2025-07-07 ✓ Approvedprice-onlyABEO · 2025-07-11 CRLprice-onlyCAPR · 2025-07-11 CRLsource-verifiedRARE · 2025-07-11 CRLprice-onlyCUE · 2025-07-16 CRLprice-onlyGSK · 2025-07-17 ✓ Approvedprice-onlyRHHBY · 2025-07-18 CRLprice-onlyREPL · 2025-07-22 CRLsource-verifiedAPLS · 2025-07-28 ✓ Approvedprice-onlyASND · 2025-07-28 ✓ Approvedprice-onlyPHIO · 2025-07-28 CRLprice-onlyPTCT · 2025-07-28 ✓ Approvedprice-onlyANIK · 2025-07-30 ✓ Approvedprice-onlyREGN · 2025-07-30 CRLprice-onlyZLAB · 2025-07-30 CRLprice-onlyLENZ · 2025-07-31 ✓ Approvedprice-only

August 2025

JAZZ · 2025-08-06 ✓ Approvedprice-onlyTEVA · 2025-08-06 ✓ Approvedprice-onlyAMPH · 2025-08-11 ✓ Approvedprice-onlyPHRRF · 2025-08-11 ✓ Approvedprice-onlyINSM · 2025-08-12 ✓ Approvedprice-onlyIBRX · 2025-08-13 CRLprice-onlyNVO · 2025-08-15 ✓ Approvedprice-onlyPGEN · 2025-08-15 ✓ Approvedprice-onlyTNXP · 2025-08-15 ✓ Approvedprice-onlyPTCT · 2025-08-19 CRLprice-onlyIONI · 2025-08-21 ✓ Approvedprice-onlyIONS · 2025-08-21 ✓ Approvedprice-onlyVALN · 2025-08-25 ✓ Approvedprice-onlyMRKR · 2025-08-26 CRLprice-onlyBNTX · 2025-08-27 ✓ Approvedprice-onlyLGND · 2025-08-27 ✓ Approvedprice-onlyMRNA · 2025-08-27 ✓ Approvedprice-onlyNVAX · 2025-08-27 ✓ Approvedprice-onlyPFE · 2025-08-27 ✓ Approvedprice-onlyPRTA · 2025-08-27 ✓ Approvedprice-onlyTVTX · 2025-08-27 ✓ Approvedprice-onlyOTLK · 2025-08-28 CRLsource-verifiedTEVA · 2025-08-28 ✓ Approvedprice-onlyBIIB · 2025-08-29 ✓ Approvedprice-onlySNY · 2025-08-29 ✓ Approvedprice-only

September 2025

AMRX · 2025-09-04 ✓ Approvedprice-onlyTAK · 2025-09-05 ✓ Approvedprice-onlyJNJ · 2025-09-09 ✓ Approvedprice-onlyAMRX · 2025-09-11 ✓ Approvedprice-onlyGMAB · 2025-09-12 CRLprice-onlyKRYS · 2025-09-15 ✓ Approvedprice-onlyINCY · 2025-09-19 ✓ Approvedprice-onlyJNJ · 2025-09-19 ✓ Approvedprice-onlyMRK · 2025-09-19 ✓ Approvedprice-onlyAMRX · 2025-09-23 ✓ Approvedprice-onlyBIIB · 2025-09-23 CRLprice-onlyIONS · 2025-09-23 CRLprice-onlySRRK · 2025-09-23 CRLprice-onlyCRNX · 2025-09-25 ✓ Approvedprice-onlyLLY · 2025-09-25 ✓ Approvedprice-onlyJNJ · 2025-09-29 ✓ Approvedprice-onlyNVS · 2025-09-30 ✓ Approvedprice-only

October 2025

FBIO · 2025-10-01 CRLprice-onlyJAZZ · 2025-10-02 ✓ Approvedprice-onlyRHHBY · 2025-10-02 ✓ Approvedprice-onlyARQT · 2025-10-06 ✓ Approvedprice-onlyREGN · 2025-10-08 ✓ Approvedprice-onlyTEVA · 2025-10-10 ✓ Approvedprice-onlyABBV · 2025-10-13 ✓ Approvedprice-onlyCGEM · 2025-10-13 CRLprice-onlyNVO · 2025-10-15 ✓ Approvedprice-onlyAMGN · 2025-10-17 ✓ Approvedprice-onlyAZN · 2025-10-17 ✓ Approvedprice-onlyREGN · 2025-10-17 CRLprice-onlySNSE · 2025-10-17 CRLsource-verifiedGKOS · 2025-10-20 ✓ Approvedprice-onlyRHHBY · 2025-10-20 ✓ Approvedprice-onlyGSK · 2025-10-23 ✓ Approvedprice-onlyBAYRY · 2025-10-24 ✓ Approvedprice-onlySNDX · 2025-10-24 ✓ Approvedprice-onlyLLY · 2025-10-27 ✓ Approvedprice-onlyMRK · 2025-10-27 ✓ Approvedprice-onlyONCY · 2025-10-28 ✓ Approvedprice-onlyAMRX · 2025-10-29 ✓ Approvedprice-only

November 2025

ALVO · 2025-11-02 CRLprice-onlyAGIO · 2025-11-03 ✓ Approvedprice-onlyESLA · 2025-11-03 CRLsource-verifiedBHVN · 2025-11-04 CRLprice-onlyIBRX · 2025-11-05 CRLprice-onlyCLDX · 2025-11-06 CRLprice-onlyJNJ · 2025-11-06 ✓ Approvedprice-onlyBCAB · 2025-11-07 ✓ Approvedprice-onlyCYTK · 2025-11-07 CRLprice-onlyJNJ · 2025-11-07 ✓ Approvedprice-onlyRPRX · 2025-11-07 CRLprice-onlyENGN · 2025-11-11 CRLsource-verifiedAMRX · 2025-11-13 ✓ Approvedprice-onlyKURA · 2025-11-13 ✓ Approvedprice-onlyOGN · 2025-11-17 ✓ Approvedprice-onlyABBV · 2025-11-18 ✓ Approvedprice-onlyARWR · 2025-11-18 ✓ Approvedprice-onlyGMAB · 2025-11-18 ✓ Approvedprice-onlyKZIA · 2025-11-18 CRLprice-onlyAMGN · 2025-11-19 ✓ Approvedprice-onlyREGN · 2025-11-19 ✓ Approvedprice-onlyTARA · 2025-11-19 CRLprice-onlyAZN · 2025-11-20 ✓ Approvedprice-onlyBAYRY · 2025-11-20 ✓ Approvedprice-onlyALPMY · 2025-11-21 ✓ Approvedprice-onlyMRK · 2025-11-21 ✓ Approvedprice-onlyPFE · 2025-11-21 ✓ Approvedprice-onlyNVS · 2025-11-24 ✓ Approvedprice-onlyAZN · 2025-11-25 ✓ Approvedprice-onlyRHHBY · 2025-11-25 ✓ Approvedprice-onlySRPT · 2025-11-25 ✓ Approvedprice-only

December 2025

AMRX · 2025-12-01 ✓ Approvedprice-onlyJANX · 2025-12-01 ✓ Approvedprice-onlyAMRN · 2025-12-02 ✓ Approvedprice-onlyLLY · 2025-12-03 ✓ Approvedprice-onlyAXGN · 2025-12-04 ✓ Approvedprice-onlyBMY · 2025-12-04 ✓ Approvedprice-onlyPLRX · 2025-12-04 CRLprice-onlyPRTC · 2025-12-05 CRLprice-onlyCASI · 2025-12-07 CRLprice-onlyCLLS · 2025-12-07 CRLprice-onlyGLPG · 2025-12-07 CRLprice-onlyIMMX · 2025-12-07 CRLprice-onlyALXO · 2025-12-08 CRLprice-onlyAUTL · 2025-12-08 CRLprice-onlyLYEL · 2025-12-08 CRLprice-onlyNRIX · 2025-12-08 CRLprice-onlyONC · 2025-12-08 CRLprice-onlyAAPG · 2025-12-09 CRLprice-onlyAMGN · 2025-12-11 ✓ Approvedprice-onlyGSK · 2025-12-11 ✓ Approvedprice-onlyACAD · 2025-12-12 ✓ Approvedprice-onlyBCRX · 2025-12-12 ✓ Approvedprice-onlyAMPH · 2025-12-15 ✓ Approvedprice-onlyAZN · 2025-12-15 ✓ Approvedprice-onlyDSNKY · 2025-12-15 ✓ Approvedprice-onlyINVA · 2025-12-15 ✓ Approvedprice-onlyJNJ · 2025-12-15 ✓ Approvedprice-onlyMIST · 2025-12-15 ✓ Approvedprice-onlyGILD · 2025-12-16 ✓ Approvedprice-onlyALPMY · 2025-12-17 CRLprice-onlyMRK · 2025-12-17 CRLprice-onlyPFE · 2025-12-17 CRLprice-onlyCOCP · 2025-12-18 ✓ Approvedprice-onlyJNJ · 2025-12-18 ✓ Approvedprice-onlyCYTK · 2025-12-19 ✓ Approvedprice-onlyPBM · 2025-12-19 ✓ Approvedprice-onlyAMRX · 2025-12-22 ✓ Approvedprice-onlyCRSP · 2025-12-22 CRLprice-onlyNVO · 2025-12-22 ✓ Approvedprice-onlyRHHBY · 2025-12-22 ✓ Approvedprice-onlyAGIO · 2025-12-23 ✓ Approvedprice-onlyOMER · 2025-12-24 ✓ Approvedprice-onlySNY · 2025-12-28 CRLprice-onlyVNDA · 2025-12-30 ✓ Approvedprice-onlyCORT · 2025-12-31 CRLprice-onlyOTLK · 2025-12-31 CRLprice-only