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calendar

6,528 catalysts · 5,402 approval · 5,000 device 510k · 4,728 grant · 3,045 8k filing · 2,000 device pma · 2,000 device recall

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soonest latest type sponsor alpha

type: approval×type: recall×from 2023-02-24×clear all

type

approval5,402
device 510k5,000
grant4,728
8k filing3,045
device pma2,000
device recall2,000

recall

1,126

device adverse event1,000

earnings579

phase 2 completion172

therapy area

no tagged catalysts yet

Week of Feb 20, 2023

›Feb 24, 2023approval1264d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

Sponsor: ABBVIE. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL

full page →divalproex sodium DR →fda approvals ↗

›Feb 24, 2023approval1264d agoDEPAKOTE ER (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

Sponsor: ABBVIE. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →divalproex sodium DR →fda approvals ↗

›Feb 24, 2023approval1264d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

Sponsor: ABBVIE. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →divalproex sodium DR →fda approvals ↗

›Feb 24, 2023approval1264d agoOLANZAPINE — FDA approvalolanzapine ODT

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

full page →olanzapine ODT →fda approvals ↗

Week of Feb 27, 2023

›Feb 27, 2023approval1261d agoCABENUVA KIT (CABOTEGRAVIR) — FDA approvalViiV Healthcare Company

Sponsor: VIIV HLTHCARE. Form: SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →fda approvals ↗

›Feb 27, 2023approval

Week of Mar 6, 2023

›Mar 6, 2023approval1254d agoSTELARA (USTEKINUMAB) — FDA approvalJOHNSON & JOHNSON

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

full page →fda approvals ↗

›Mar 6, 2023approval

Week of Mar 13, 2023

›Mar 13, 2023approval1247d agoSUBLOCADE (BUPRENORPHINE) — FDA approvalbuprenorphine LA

Sponsor: INDIVIOR. Form: SOLUTION, EXTENDED RELEASE. Route: SUBCUTANEOUS

full page →buprenorphine LA →fda approvals ↗

›Mar 13, 2023approval

Week of Mar 20, 2023

›Mar 20, 2023approval1240d agoBALVERSA (ERDAFITINIB) — FDA approvalerdafitinib

Sponsor: JANSSEN BIOTECH. Form: TABLET. Route: ORAL

full page →erdafitinib →fda approvals ↗

›Mar 20, 2023approval

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page 1 of 131

1261d ago

YUSIMRY (ADALIMUMAB-AQVH) — FDA approvalYUSIMRY

Sponsor: COHERUS BIOSCIENCES INC. Form: INJECTABLE. Route: INJECTION

full page →YUSIMRY →fda approvals ↗

›Feb 28, 2023approval1260d agoSKYCLARYS (OMAVELOXOLONE) — FDA approvalReata Pharmaceuticals Inc

Sponsor: BIOGEN US. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Feb 28, 2023approval1260d agoACETAMINOPHEN AND IBUPROFEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: L PERRIGO CO. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Mar 2, 2023approval1258d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: ZYDUS LIFESCIENCES. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

›Mar 3, 2023approval1257d agoARTESUNATE — FDA approvalARTESUNATE

Sponsor: AMIVAS. Form: POWDER. Route: INTRAVENOUS

full page →ARTESUNATE →fda approvals ↗

›Mar 3, 2023approval1257d agoFLUOROURACIL — FDA approvalEfudex

Sponsor: ALEMBIC. Form: INJECTABLE. Route: INJECTION

full page →Efudex →fda approvals ↗

›Mar 3, 2023approval1257d agoFENTANYL CITRATE — FDA approvalEffentora

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →Effentora →fda approvals ↗

›Mar 3, 2023approval1257d agoTRELSTAR (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR

full page →triptorelin pamoate ER →fda approvals ↗

›Mar 3, 2023approval1257d agoTRELSTAR (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR

full page →triptorelin pamoate ER →fda approvals ↗

›Mar 3, 2023approval1257d agoTRELSTAR (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR

full page →triptorelin pamoate ER →fda approvals ↗

1254d ago

STELARA (USTEKINUMAB) — FDA approvalustekinumab

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

full page →ustekinumab →fda approvals ↗

›Mar 7, 2023approval1253d agoZOLEDRONIC ACID — FDA approvalNOVARTIS AG

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

full page →fda approvals ↗

›Mar 7, 2023approval1253d agoDILTIAZEM HYDROCHLORIDE — FDA approvalBausch Health US LLC

Sponsor: AMTA. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Mar 8, 2023approval1252d agoATORVASTATIN CALCIUM — FDA approvalSciegen Pharmaceuticals Inc

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

full page →fda approvals ↗

›Mar 8, 2023approval1252d agoTOPIRAMATE — FDA approvaltopiramate ER

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

full page →topiramate ER →fda approvals ↗

›Mar 8, 2023approval1252d agoTOPIRAMATE — FDA approvaltopiramate ER

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

full page →topiramate ER →fda approvals ↗

›Mar 9, 2023approval1251d agoOLANZAPINE — FDA approvalZydus Therapeutics Inc

Sponsor: ZYDUS PHARMS. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →fda approvals ↗

›Mar 10, 2023approval1250d agoDAYBUE (TROFINETIDE) — FDA approvaltrofinetide

Sponsor: ACADIA PHARMS INC. Form: SOLUTION. Route: ORAL

full page →trofinetide →fda approvals ↗

›Mar 10, 2023approval1250d agoTOPIRAMATE — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

Sponsor: ACTAVIS LABS FL. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Mar 10, 2023approval1250d agoTOPIRAMATE — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

Sponsor: ACTAVIS LABS FL. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

1247d ago

SUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: INDIVIOR. Form: FILM. Route: BUCCAL, SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Mar 15, 2023approval1245d agoILLUCCIX (GALLIUM GA-68 GOZETOTIDE) — FDA approvalILLUCCIX

Sponsor: TELIX. Form: POWDER. Route: INTRAVENOUS

full page →ILLUCCIX →fda approvals ↗

›Mar 15, 2023approval1245d agoENOXAPARIN SODIUM (PRESERVATIVE FREE) (ENOXAPARIN SODIUM) — FDA approvalenoxaparin sodium

Sponsor: SHENZHEN TECHDOW. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →enoxaparin sodium →fda approvals ↗

›Mar 15, 2023approval1245d agoALLOPURINOL — FDA approvalMylan Pharmaceuticals Inc

Sponsor: REGCON HOLDINGS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Mar 16, 2023approval1244d agoMEKINIST (TRAMETINIB) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

full page →Spexotras →fda approvals ↗

›Mar 16, 2023approval1244d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

›Mar 16, 2023approval1244d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Spexotras →fda approvals ↗

›Mar 16, 2023approval1244d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

›Mar 16, 2023approval1244d agoZOLADEX (GOSERELIN ACETATE) — FDA approvalgoserelin LA

Sponsor: TERSERA. Form: IMPLANT. Route: IMPLANTATION

full page →goserelin LA →fda approvals ↗

1240d ago

HYRIMOZ (ADALIMUMAB-ADAZ) — FDA approvalHYRIMOZ

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

full page →HYRIMOZ →fda approvals ↗

›Mar 21, 2023approval1239d agoFOLLISTIM AQ (FOLLITROPIN ALFA/BETA) — FDA approvalfollitropin beta

Sponsor: ORGANON USA LLC. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →follitropin beta →fda approvals ↗

›Mar 21, 2023approval1239d agoFOLLISTIM AQ (FOLLITROPIN ALFA/BETA) — FDA approvalfollitropin beta

Sponsor: ORGANON USA LLC. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →follitropin beta →fda approvals ↗

›Mar 21, 2023approval1239d agoFOLLISTIM AQ (FOLLITROPIN ALFA/BETA) — FDA approvalfollitropin beta

Sponsor: ORGANON USA LLC. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →follitropin beta →fda approvals ↗

›Mar 21, 2023approval1239d agoEVKEEZA (EVINACUMAB-DGNB) — FDA approvalevinacumab

Sponsor: REGENERON PHARMACEUTICALS. Form: SOLUTION. Route: INJECTION

full page →evinacumab →fda approvals ↗

›Mar 22, 2023approval1238d agoZYNYZ (RETIFANLIMAB-DLWR) — FDA approvalretifanlimab

Sponsor: INCYTE CORP. Form: INJECTABLE. Route: INTRAVENOUS

full page →retifanlimab →fda approvals ↗

›Mar 22, 2023approval1238d agoTRAZODONE HYDROCHLORIDE — FDA approvalTRAZODONE HYDROCHLORIDE

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

full page →TRAZODONE HYDROCHLORIDE →fda approvals ↗

›Mar 22, 2023approval1238d agoTRAZODONE HYDROCHLORIDE — FDA approvalTRAZODONE HYDROCHLORIDE

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →TRAZODONE HYDROCHLORIDE →fda approvals ↗

›Mar 22, 2023approval1238d agoDAPTOMYCIN — FDA approvalDaptomycin Novo

Sponsor: MEITHEAL. Form: POWDER. Route: INTRAVENOUS

full page →Daptomycin Novo →fda approvals ↗

›Mar 22, 2023approval1238d agoREZZAYO (REZAFUNGIN ACETATE) — FDA approvalrezafungin acetate

Sponsor: MUNDIPHARMA. Form: POWDER. Route: INTRAVENOUS

full page →rezafungin acetate →fda approvals ↗

›Mar 22, 2023approval1238d agoAMJEVITA (ADALIMUMAB-ATTO) — FDA approvalAMJEVITA

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

full page →AMJEVITA →fda approvals ↗

›Mar 22, 2023approval1238d agoCYLTEZO (ADALIMUMAB-ADBM) — FDA approvalCYLTEZO

Sponsor: BOEHRINGER INGELHEIM. Form: INJECTABLE. Route: INJECTION

full page →CYLTEZO →fda approvals ↗

›Mar 23, 2023approval1237d agoAMONDYS 45 (CASIMERSEN) — FDA approvalcasimersen

Sponsor: SAREPTA THERAPS INC. Form: SOLUTION. Route: INTRAVENOUS

full page →casimersen →fda approvals ↗

$ABBV247.97+0.78%

$JNJ261.81+0.99%

$ABBV247.97+0.78%

$INDV38.47-0.90%

$ABBV247.97+0.78%

$NVS156.79+0.29%

$INDV38.47-0.90%

$PRGO12.64-1.56%

$TLX

$NVS156.79+0.29%

$ACAD29.39+0.62%

$COGT41.53-2.03%

$REGN808.05+3.02%

$INCY121.55+0.82%

$SRPT17.18+2.38%

$AMGN417.20+1.52%

$NVS156.79+0.29%