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calendar

3,076 catalysts · 4,728 grant · 3,912 device 510k · 3,076 approval · 3,045 8k filing · 2,000 device pma · 2,000 device recall

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soonest latest type sponsor alpha

type: approval×from 2025-01-24×clear all

type

grant4,728
device 510k3,912
approval3,076
8k filing3,045
device pma2,000
device recall2,000

device adverse event

1,000

recall935

earnings579

phase 2 completion172

therapy area

no tagged catalysts yet

Week of Jan 20, 2025

›Jan 24, 2025approval564d agoMEKINIST (TRAMETINIB) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

full page →Spexotras →fda approvals ↗

›Jan 24, 2025approval564d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Spexotras →fda approvals ↗

›Jan 24, 2025approval564d agoLEQEMBI (LECANEMAB-IRMB) — FDA approvallecanemab

Sponsor: EISAI INC. Form: INJECTABLE. Route: INJECTION

full page →lecanemab →fda approvals ↗

›Jan 24, 2025approval564d agoAVTOZMA (TOCILIZUMAB-ANOH) — FDA approvalAVTOZMA

Sponsor: CELLTRION INC. Form: INJECTABLE. Route: INTRAVENOUS

full page →AVTOZMA →fda approvals ↗

›Jan 26, 2025approval562d agoNIZORAL ANTI-DANDRUFF (KETOCONAZOLE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: KRAMER. Form: SHAMPOO. Route: TOPICAL

full page →fda approvals ↗

Week of Jan 27, 2025

›Jan 27, 2025approval561d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

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

full page →carbamazepine ER →fda approvals ↗

›Jan 27, 2025approval

Week of Feb 3, 2025

›Feb 3, 2025approval554d agoVALPROIC ACID — FDA approvalCereno Scientific AB

Sponsor: CHARTWELL RX. Form: SYRUP. Route: ORAL

full page →fda approvals ↗

›Feb 4, 2025approval

Week of Feb 10, 2025

›Feb 10, 2025approval547d agoENZEEVU (AFLIBERCEPT-ABZV) — FDA approvalaflibercept biosimilar

Sponsor: SANDOZ INC. Form: INJECTABLE. Route: INJECTION

full page →aflibercept biosimilar →fda approvals ↗

›Feb 11, 2025approval

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page 1 of 62

561d ago

CARBAMAZEPINE — FDA approvalcarbamazepine ER

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

full page →carbamazepine ER →fda approvals ↗

›Jan 27, 2025approval561d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

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

full page →carbamazepine ER →fda approvals ↗

›Jan 27, 2025approval561d agoENHERTU (FAM-TRASTUZUMAB DERUXTECAN-NXKI) — FDA approvaltrastuzumab deruxtecan

Sponsor: DAIICHI SANKYO. Form: INJECTABLE. Route: INJECTION

full page →trastuzumab deruxtecan →fda approvals ↗

›Jan 27, 2025approval561d agoENHERTU (FAM-TRASTUZUMAB DERUXTECAN-NXKI) — FDA approvaltrastuzumab deruxtecan

Sponsor: DAIICHI SANKYO. Form: INJECTABLE. Route: INJECTION

full page →trastuzumab deruxtecan →fda approvals ↗

›Jan 28, 2025approval560d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

full page →pembrolizumab →fda approvals ↗

›Jan 28, 2025approval560d agoEPYSQLI (ECULIZUMAB-AAGH) — FDA approvalEPYSQLI

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTION. Route: SOLUTION

full page →EPYSQLI →fda approvals ↗

›Jan 28, 2025approval560d agoOZEMPIC (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

›Jan 29, 2025approval559d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

Sponsor: TEVA PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Jan 29, 2025approval559d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

Sponsor: TEVA PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Jan 29, 2025approval559d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

Sponsor: AVANTHI INC. Form: TABLET. Route: ORAL

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

›Jan 29, 2025approval559d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ABHAI LLC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Jan 29, 2025approval559d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ABHAI LLC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Jan 29, 2025approval559d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

›Jan 30, 2025approval558d agoBKEMV (ECULIZUMAB-AEEB) — FDA approvaleculizumab biosimilar

Sponsor: AMGEN INC. Form: INJECTABLE. Route: INJECTION

full page →eculizumab biosimilar →fda approvals ↗

›Jan 30, 2025approval558d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

›Jan 30, 2025approval558d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

›Jan 30, 2025approval558d agoJOURNAVX (SUZETRIGINE) — FDA approvalsuzetrigine

Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL

full page →suzetrigine →fda approvals ↗

›Jan 30, 2025approval558d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: SOMERSET THERAPS LLC. Form: INJECTABLE. Route: INJECTION

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Jan 31, 2025approval557d agoSOGROYA (SOMAPACITAN-BECO) — FDA approvalsomatriptan albumin bound LA

Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS

full page →somatriptan albumin bound LA →fda approvals ↗

›Jan 31, 2025approval557d agoPAXLOVID (COPACKAGED) (NIRMATRELVIR) — FDA approvalPAXLOVID (COPACKAGED)

Sponsor: PFIZER. Form: TABLET. Route: ORAL

full page →PAXLOVID (COPACKAGED) →fda approvals ↗

›Jan 31, 2025approval557d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: MACLEODS PHARMS LTD. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

›Jan 31, 2025approval557d agoUNASYN (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗

›Jan 31, 2025approval557d agoPEPCID COMPLETE (CALCIUM CARBONATE) — FDA approvalKenvue Inc.

Sponsor: KENVUE BRANDS. Form: TABLET, CHEWABLE. Route: ORAL

full page →fda approvals ↗

553d ago

GABAPENTIN — FDA approvalGABAPENTIN

Sponsor: STRIDES PHARMA. Form: CAPSULE. Route: ORAL

full page →GABAPENTIN →fda approvals ↗

›Feb 4, 2025approval553d agoGABAPENTIN — FDA approvalGABAPENTIN

Sponsor: STRIDES PHARMA. Form: CAPSULE. Route: ORAL

full page →GABAPENTIN →fda approvals ↗

›Feb 5, 2025approval552d agoBOSENTAN — FDA approvalBOSENTAN

Sponsor: NATCO PHARMA LTD. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →BOSENTAN →fda approvals ↗

›Feb 5, 2025approval552d agoRIFATER (ISONIAZID) — FDA approvalRIFATER

Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL

full page →RIFATER →fda approvals ↗

›Feb 5, 2025approval552d agoWELLBUTRIN (BUPROPION HYDROCHLORIDE) — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

›Feb 6, 2025approval551d agoFLUOROURACIL — FDA approvalExtrovis AG

Sponsor: KINDOS. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Feb 7, 2025approval550d agoZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →ZEPBOUND →fda approvals ↗

›Feb 7, 2025approval550d agoONGENTYS (OPICAPONE) — FDA approvalopicapone

Sponsor: AMNEAL. Form: CAPSULE. Route: ORAL

full page →opicapone →fda approvals ↗

546d ago

CAMCEVI KIT (LEUPROLIDE MESYLATE) — FDA approvalForesee Pharmaceuticals Co Ltd

Sponsor: ACCORD. Form: EMULSION. Route: SUBCUTANEOUS

full page →fda approvals ↗

›Feb 11, 2025approval546d agoEVRYSDI (RISDIPLAM) — FDA approvalEVRYSDI

Sponsor: GENENTECH INC. Form: TABLET. Route: ORAL

full page →EVRYSDI →fda approvals ↗

›Feb 11, 2025approval546d agoEVRYSDI (RISDIPLAM) — FDA approvalEVRYSDI

Sponsor: GENENTECH INC. Form: FOR SOLUTION. Route: ORAL

full page →EVRYSDI →fda approvals ↗

›Feb 11, 2025approval546d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

›Feb 11, 2025approval546d agoPEPCID COMPLETE (CALCIUM CARBONATE) — FDA approvalKenvue Inc.

Sponsor: KENVUE BRANDS. Form: TABLET, CHEWABLE. Route: ORAL

full page →fda approvals ↗

›Feb 12, 2025approval545d agoMETHYLPREDNISOLONE ACETATE — FDA approvalMETHYLPREDNISOLONE ACETATE

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

full page →METHYLPREDNISOLONE ACETATE →fda approvals ↗

›Feb 12, 2025approval545d agoMETHYLPREDNISOLONE ACETATE — FDA approvalMETHYLPREDNISOLONE ACETATE

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

full page →METHYLPREDNISOLONE ACETATE →fda approvals ↗

›Feb 12, 2025approval545d agoIZERVAY (AVACINCAPTAD PEGOL SODIUM) — FDA approvalavacincaptad pegol sodium

Sponsor: ASTELLAS. Form: SOLUTION. Route: INTRAVITREAL

full page →avacincaptad pegol sodium →fda approvals ↗

›Feb 12, 2025approval545d agoPAXLOVID (COPACKAGED) (NIRMATRELVIR) — FDA approvalPAXLOVID (COPACKAGED)

Sponsor: PFIZER. Form: TABLET. Route: ORAL

full page →PAXLOVID (COPACKAGED) →fda approvals ↗

›Feb 12, 2025approval545d agoSELARSDI (USTEKINUMAB-AEKN) — FDA approvalAlvotech

Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Feb 12, 2025approval545d agoVICTOZA (LIRAGLUTIDE) — FDA approvalSaxenda

Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS

full page →Saxenda →fda approvals ↗

$NVS156.79+0.29%

$VERX12.13+1.63%

$AMGN417.20+1.52%

$NVS156.79+0.29%

$AVTR13.73+1.03%

$PFE27.05+1.08%

$NVO47.73+0.99%

$PFE27.05+1.08%

$KVUE19.03-1.04%

$NSRX2.7000-1.82%

$LLY1231.94+3.90%

$AMRX17.88-1.43%

$IGC0.2670+0.41%

$KVUE19.03-1.04%

$NVO47.73+0.99%

$PFE27.05+1.08%

$ALVO3.7700-1.05%