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calendar

18,994 catalysts · 18,987 approval · 7,208 phase readout · 5,000 device 510k · 4,728 grant · 3,603 8k filing · 2,000 device pma

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soonest latest type sponsor alpha

type: approval×type: pdufa×clear all

type

approval18,987
phase readout7,208
device 510k5,000
grant4,728
8k filing3,603
device pma2,000
device recall

2,000

recall1,126

device adverse event1,000

earnings585

therapy area

Dermatology1
Infectious Disease1

Week of Apr 6, 2026

›Apr 10, 2026approval142d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

Sponsor: TORRENT PHARMS. Form: TABLET. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

›Apr 10, 2026approval142d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

Sponsor: TORRENT PHARMS. Form: TABLET. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

›Apr 10, 2026approval142d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

Sponsor: TORRENT PHARMS. Form: TABLET. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

›Apr 10, 2026approval142d agoMETHYLPREDNISOLONE ACETATE — FDA approvalMETHYLPREDNISOLONE ACETATE

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

full page →METHYLPREDNISOLONE ACETATE →fda approvals ↗

›Apr 10, 2026approval142d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

Sponsor: GLENMARK PHARMS LTD. Form: TABLET. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

›Apr 10, 2026approval142d agoLIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% (LIDOCAINE HYDROCHLORIDE) — FDA approvalLaryng-O-Jet

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →Laryng-O-Jet →fda approvals ↗

›Apr 10, 2026approval142d agoDILTIAZEM HYDROCHLORIDE — FDA approvalSciegen Pharmaceuticals Inc

Sponsor: SCIEGEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Apr 10, 2026approval142d agoMETHYLPREDNISOLONE — FDA approvalMEDROL

Sponsor: SANDOZ. Form: TABLET. Route: ORAL

full page →MEDROL →fda approvals ↗

›Apr 10, 2026approval142d agoMYCOPHENOLATE MOFETIL — FDA approvalMYCOPHENOLATE MOFETIL

Sponsor: STRIDES PHARMA INTL. Form: FOR SUSPENSION. Route: ORAL

full page →MYCOPHENOLATE MOFETIL →fda approvals ↗

Week of Apr 13, 2026

›Apr 13, 2026approval139d agoOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: MICRO LABS. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

›Apr 13, 2026approval

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page 379 of 380

139d ago

VANFLYTA (QUIZARTINIB DIHYDROCHLORIDE) — FDA approvalquizartinib dihydrochloride

Sponsor: DAIICHI SANKYO INC. Form: TABLET. Route: ORAL

full page →quizartinib dihydrochloride →fda approvals ↗

›Apr 13, 2026approval139d agoLAMOTRIGINE — FDA approvalAlembic Pharmaceuticals Inc

Sponsor: ALEMBIC PHARMS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Apr 13, 2026approval139d agoLAMOTRIGINE — FDA approvalAlembic Pharmaceuticals Inc

Sponsor: ALEMBIC PHARMS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Apr 13, 2026approval139d agoLURASIDONE HYDROCHLORIDE — FDA approvalLURASIDONE HYDROCHLORIDE

Sponsor: TORRENT. Form: TABLET. Route: ORAL

full page →LURASIDONE HYDROCHLORIDE →fda approvals ↗

›Apr 13, 2026approval139d agoLURASIDONE HYDROCHLORIDE — FDA approvalLURASIDONE HYDROCHLORIDE

Sponsor: TORRENT. Form: TABLET. Route: ORAL

full page →LURASIDONE HYDROCHLORIDE →fda approvals ↗

›Apr 13, 2026approval139d agoSPRAVATO (ESKETAMINE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL

full page →fda approvals ↗

›Apr 13, 2026approval139d agoARTESUNATE — FDA approvalARTESUNATE

Sponsor: AMIVAS. Form: POWDER. Route: INTRAVENOUS

full page →ARTESUNATE →fda approvals ↗

›Apr 13, 2026approval139d agoPIMOZIDE — FDA approvalPIMOZIDE

Sponsor: NOVITIUM PHARMA. Form: TABLET. Route: ORAL

full page →PIMOZIDE →fda approvals ↗

›Apr 13, 2026approval139d agoFILSPARI (SPARSENTAN) — FDA approvalsparsentan

Sponsor: TRAVERE. Form: TABLET. Route: ORAL

full page →sparsentan →fda approvals ↗

›Apr 14, 2026approval138d agoMILNACIPRAN HYDROCHLORIDE — FDA approvalMILNACIPRAN HYDROCHLORIDE

Sponsor: BRECKENRIDGE. Form: TABLET. Route: ORAL

full page →MILNACIPRAN HYDROCHLORIDE →fda approvals ↗

›Apr 14, 2026approval138d agoMILNACIPRAN HYDROCHLORIDE — FDA approvalMILNACIPRAN HYDROCHLORIDE

Sponsor: BRECKENRIDGE. Form: TABLET. Route: ORAL

full page →MILNACIPRAN HYDROCHLORIDE →fda approvals ↗

›Apr 14, 2026approval138d agoMILNACIPRAN HYDROCHLORIDE — FDA approvalMILNACIPRAN HYDROCHLORIDE

Sponsor: BRECKENRIDGE. Form: TABLET. Route: ORAL

full page →MILNACIPRAN HYDROCHLORIDE →fda approvals ↗

›Apr 14, 2026approval138d agoDANZITEN (NILOTINIB TARTRATE) — FDA approvalDANZITEN

Sponsor: AZURITY. Form: TABLET. Route: ORAL

full page →DANZITEN →fda approvals ↗

›Apr 14, 2026approval138d agoSONAZINE (CHLORPROMAZINE HYDROCHLORIDE) — FDA approvalSaptalis Pharmaceuticals LLC

Sponsor: SAPTALIS PHARMS. Form: CONCENTRATE. Route: ORAL

full page →fda approvals ↗

›Apr 14, 2026approval138d agoRYTELO (IMETELSTAT SODIUM) — FDA approvalimetelstat sodium

Sponsor: GERON. Form: POWDER. Route: INTRAVENOUS

full page →imetelstat sodium →fda approvals ↗

›Apr 14, 2026approval138d agoMILNACIPRAN HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Apr 14, 2026approval138d agoBOSENTAN — FDA approvalBOSENTAN

Sponsor: WATSON LABS INC. Form: TABLET. Route: ORAL

full page →BOSENTAN →fda approvals ↗

›Apr 14, 2026approval138d agoBOSENTAN — FDA approvalBOSENTAN

Sponsor: WATSON LABS INC. Form: TABLET. Route: ORAL

full page →BOSENTAN →fda approvals ↗

›Apr 14, 2026approval138d agoCANAGLIFLOZIN — FDA approvalCANAGLIFLOZIN

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →CANAGLIFLOZIN →fda approvals ↗

›Apr 14, 2026approval138d agoLACTULOSE — FDA approvalCUMBERLAND PHARMACEUTICALS INC

Sponsor: CUMBERLAND PHARMS. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗

›Apr 14, 2026approval138d agoABREVA (DOCOSANOL) — FDA approvalPL Developments Copiague LLC

Sponsor: HALEON US HOLDINGS. Form: CREAM. Route: TOPICAL

full page →fda approvals ↗

›Apr 14, 2026approval138d agoBOSENTAN — FDA approvalZydus Therapeutics Inc

Sponsor: ZYDUS PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Apr 14, 2026approval138d agoBOSENTAN — FDA approvalZydus Therapeutics Inc

Sponsor: ZYDUS PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Apr 15, 2026approval137d agoGLYCEROL PHENYLBUTYRATE — FDA approvalLupin Ltd

Sponsor: TEVA PHARMS INC. Form: LIQUID. Route: ORAL

full page →fda approvals ↗

›Apr 15, 2026approval137d agoDIACOMIT (STIRIPENTOL) — FDA approvalstiripentol

Sponsor: BIOCODEX SA. Form: CAPSULE. Route: ORAL

full page →stiripentol →fda approvals ↗

›Apr 15, 2026approval137d agoSTELARA (USTEKINUMAB) — FDA approvalJOHNSON & JOHNSON

Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Apr 15, 2026approval137d agoALENDRONATE SODIUM — FDA approvalALENDRONATE SODIUM

Sponsor: AUROBINDO PHARMA. Form: TABLET. Route: ORAL

full page →ALENDRONATE SODIUM →fda approvals ↗

›Apr 15, 2026approval137d agoONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE) — FDA approvalDR REDDYS LABORATORIES LTD

Sponsor: ONESOURCE SPECIALTY. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Apr 15, 2026approval137d agoMETHOTREXATE SODIUM — FDA approvalMaxtrex

Sponsor: ALEMBIC. Form: INJECTABLE. Route: INJECTION

full page →Maxtrex →fda approvals ↗

›Apr 15, 2026approval137d agoONDANSETRON HYDROCHLORIDE — FDA approvalRedHill Biopharma Ltd.

Sponsor: ONESOURCE SPECIALTY. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Apr 15, 2026approval137d agoWAINUA (AUTOINJECTOR) (EPLONTERSEN SODIUM) — FDA approvaleplontersen sodium

Sponsor: ASTRAZENECA AB. Form: SOLUTION. Route: SUBCUTANEOUS

full page →eplontersen sodium →fda approvals ↗

›Apr 15, 2026approval137d agoGLYCEROL PHENYLBUTYRATE — FDA approvalGLYCEROL PHENYLBUTYRATE

Sponsor: AUROBINDO PHARMA. Form: LIQUID

full page →GLYCEROL PHENYLBUTYRATE →fda approvals ↗

›Apr 15, 2026approval137d agoRAMELTEON — FDA approvalRAMELTEON

Sponsor: MICRO LABS. Form: TABLET. Route: ORAL

full page →RAMELTEON →fda approvals ↗

›Apr 15, 2026approval137d agoALENDRONATE SODIUM — FDA approvalOrganon & Co.

Sponsor: IPCA LABS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Apr 15, 2026approval137d agoSODIUM BICARBONATE — FDA approvalSODIUM BICARBONATE

Sponsor: ASPIRO. Form: SOLUTION. Route: INTRAVENOUS

full page →SODIUM BICARBONATE →fda approvals ↗

›Apr 15, 2026approval137d agoGLYCEROL PHENYLBUTYRATE — FDA approvalGLYCEROL PHENYLBUTYRATE

Sponsor: MSN. Form: LIQUID. Route: ORAL

full page →GLYCEROL PHENYLBUTYRATE →fda approvals ↗

›Apr 15, 2026approval137d agoDEXTROMETHORPHAN POLISTIREX — FDA approvalDEXTROMETHORPHAN POLISTIREX

Sponsor: AUROBINDO PHARMA LTD. Form: SUSPENSION, EXTENDED RELEASE. Route: ORAL

full page →DEXTROMETHORPHAN POLISTIREX →fda approvals ↗

›Apr 15, 2026approval137d agoDIACOMIT (STIRIPENTOL) — FDA approvalstiripentol

Sponsor: BIOCODEX SA. Form: FOR SUSPENSION. Route: ORAL

full page →stiripentol →fda approvals ↗

›Apr 15, 2026approval137d agoZOLEDRONIC ACID — FDA approvalNOVARTIS AG

Sponsor: MYLAN LABS LTD. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

›Apr 15, 2026approval137d agoSTELARA (USTEKINUMAB) — FDA approvalustekinumab

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →ustekinumab →fda approvals ↗

$GERN1.5100-1.31%

$TVTX65.67-2.74%

$AMRX17.54-2.61%

$CPIX8.4600-2.20%

$JNJ268.04+0.85%

$AZN164.52-1.05%

$RDHL0.7390+6.64%

$OGN13.760.00%

$NVS153.81-0.54%

$RDY12.18+0.16%