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calendar

6,938 catalysts · 5,812 approval · 5,000 device 510k · 4,728 grant · 3,111 8k filing · 2,000 device pma · 2,000 device recall

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soonest latest type sponsor alpha

type: approval×type: recall×from 2022-08-08×clear all

type

approval5,812
device 510k5,000
grant4,728
8k filing3,111
device pma2,000
device recall2,000

recall

1,126

device adverse event1,000

earnings583

phase 2 completion172

therapy area

no tagged catalysts yet

Week of Aug 8, 2022

›Aug 8, 2022approval1465d agoVIGADRONE (VIGABATRIN) — FDA approvalVIGABATRIN

Sponsor: AUCTA. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

›Aug 8, 2022approval1465d agoVIGADRONE (VIGABATRIN) — FDA approvalVIGABATRIN

Sponsor: AUCTA. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

›Aug 8, 2022approval1465d agoVIGADRONE (VIGABATRIN) — FDA approvalVIGABATRIN

Sponsor: AUCTA. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

›Aug 8, 2022approval1465d agoVIGADRONE (VIGABATRIN) — FDA approvalVIGABATRIN

Sponsor: AUCTA. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

›Aug 11, 2022approval1462d agoENHERTU (FAM-TRASTUZUMAB DERUXTECAN-NXKI) — FDA approvaltrastuzumab deruxtecan

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

full page →trastuzumab deruxtecan →fda approvals ↗

›Aug 12, 2022approval1461d agoCETRORELIX ACETATE — FDA approvalEMD Serono Inc

Sponsor: TEVA PHARMS INC. Form: POWDER. Route: SUBCUTANEOUS

full page →fda approvals ↗

Week of Aug 15, 2022

›Aug 15, 2022approval1458d agoBYOOVIZ (RANIBIZUMAB-NUNA) — FDA approvalBYOOVIZ

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

full page →BYOOVIZ →fda approvals ↗

›Aug 15, 2022approval

Week of Aug 22, 2022

›Aug 22, 2022approval1451d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

›Aug 22, 2022approval

Week of Aug 29, 2022

›Aug 29, 2022approval1444d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

›Aug 29, 2022approval

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page 1 of 139

1458d ago

HADLIMA (ADALIMUMAB-BWWD) — FDA approvalHADLIMA

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

full page →HADLIMA →fda approvals ↗

›Aug 16, 2022approval1457d agoTOBRADEX ST (DEXAMETHASONE) — FDA approvalOCULAR THERAPEUTIX, INC

Sponsor: HARROW EYE. Form: SUSPENSION/DROPS. Route: OPHTHALMIC

full page →fda approvals ↗

›Aug 16, 2022approval1457d agoTOBRADEX ST (DEXAMETHASONE) — FDA approvalOCULAR THERAPEUTIX, INC

Sponsor: HARROW EYE. Form: SUSPENSION/DROPS. Route: OPHTHALMIC

full page →fda approvals ↗

›Aug 16, 2022approval1457d agoTOBRADEX ST (DEXAMETHASONE) — FDA approvalOCULAR THERAPEUTIX, INC

Sponsor: HARROW EYE. Form: SUSPENSION/DROPS. Route: OPHTHALMIC

full page →fda approvals ↗

›Aug 16, 2022approval1457d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Aug 16, 2022approval1457d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

›Aug 16, 2022approval1457d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗

›Aug 16, 2022approval1457d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

Sponsor: IMMUNEX. Form: SYRINGE

full page →fda approvals ↗

›Aug 16, 2022approval1457d agoXELSTRYM (DEXTROAMPHETAMINE) — FDA approvalNoven Pharmaceuticals Inc

Sponsor: NOVEN PHARMS INC. Form: SYSTEM. Route: TRANSDERMAL

full page →fda approvals ↗

›Aug 17, 2022approval1456d agoACTIQ (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: CEPHALON. Form: TROCHE/LOZENGE. Route: TRANSMUCOSAL

full page →fda approvals ↗

›Aug 17, 2022approval1456d agoFENTORA (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: CEPHALON. Form: TABLET. Route: BUCCAL, SUBLINGUAL

full page →fda approvals ↗

›Aug 18, 2022approval1455d agoMEROPENEM — FDA approvalHQ Speciality Pharma

Sponsor: BROOKS STERISCIENCE. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Aug 18, 2022approval1455d agoAUVELITY (BUPROPION HYDROCHLORIDE) — FDA approval(bupropion hydrochloride + dextromethorphan) ER

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

full page →(bupropion hydrochloride + dextromethorphan) ER →fda approvals ↗

›Aug 19, 2022approval1454d agoGLEEVEC (IMATINIB MESYLATE) — FDA approvalImatinib Mesylate Shilpa

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Imatinib Mesylate Shilpa →fda approvals ↗

1451d ago

BUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

›Aug 22, 2022approval1451d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

›Aug 22, 2022approval1451d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

›Aug 22, 2022approval1451d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

›Aug 22, 2022approval1451d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

›Aug 22, 2022approval1451d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

›Aug 23, 2022approval1450d agoKETALAR (KETAMINE HYDROCHLORIDE) — FDA approvalPar Pharmaceutical Inc

Sponsor: PH HEALTH. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Aug 23, 2022approval1450d agoCLARAVIS (ISOTRETINOIN) — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

›Aug 23, 2022approval1450d agoAMNESTEEM (ISOTRETINOIN) — FDA approvalMylan Pharmaceuticals Inc

Sponsor: MYLAN PHARMS INC. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Aug 23, 2022approval1450d agoCLARAVIS (ISOTRETINOIN) — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

›Aug 23, 2022approval1450d agoZENATANE (ISOTRETINOIN) — FDA approvalISOTRETINOIN

Sponsor: DR REDDYS LABS LTD. Form: CAPSULE. Route: ORAL

full page →ISOTRETINOIN →fda approvals ↗

›Aug 23, 2022approval1450d agoSUBLOCADE (BUPRENORPHINE) — FDA approvalbuprenorphine LA

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

full page →buprenorphine LA →fda approvals ↗

›Aug 23, 2022approval1450d agoVANTAS (HISTRELIN ACETATE) — FDA approvalEndo Pharmaceuticals Inc

Sponsor: ENDO OPERATIONS. Form: IMPLANT. Route: SUBCUTANEOUS

full page →fda approvals ↗

›Aug 24, 2022approval1449d agoWEGOVY (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

›Aug 24, 2022approval1449d agoMYORISAN (ISOTRETINOIN) — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: UPSHER SMITH LABS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Aug 24, 2022approval1449d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: UPSHER SMITH LABS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Aug 24, 2022approval1449d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: UPSHER SMITH LABS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Aug 24, 2022approval1449d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: AMNEAL PHARMS NY. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗