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calendar

24,919 catalysts · 5,282 approval · 5,000 device 510k · 4,728 grant · 3,118 8k filing · 2,000 device pma · 2,000 device recall

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soonest latest type sponsor alpha

from 2023-04-28×clear all

type

approval5,282
device 510k5,000
grant4,728
8k filing3,118
device pma2,000
device recall2,000

recall

1,126

device adverse event1,000

earnings583

phase 2 completion172

therapy area

Oncology148
Infectious Disease46
Cardiology37
Immunology35
Dermatology31
Pulmonology22
Women's Health19
Ophthalmology16
Pain15

Week of Jul 3, 2023

›Jul 3, 2023approval1136d agoSUBLOCADE (BUPRENORPHINE) — FDA approvalbuprenorphine LA

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

full page →buprenorphine LA →fda approvals ↗

›Jul 3, 2023approval1136d agoNUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approvaltapentadol hydrochloride ER

Sponsor: COLLEGIUM PHARM INC. Form: SOLUTION. Route: ORAL

full page →tapentadol hydrochloride ER →fda approvals ↗

›Jul 5, 2023approval1134d agoGLATOPA (GLATIRAMER ACETATE) — FDA approvalGLATIRAMER ACETATE

Sponsor: SANDOZ. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →GLATIRAMER ACETATE →fda approvals ↗

›Jul 5, 2023approval1134d agoVICTOZA (LIRAGLUTIDE) — FDA approvalSaxenda

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

full page →Saxenda →fda approvals ↗

›Jul 6, 2023approval1133d agoLEQEMBI (LECANEMAB-IRMB) — FDA approvallecanemab

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

full page →lecanemab →fda approvals ↗

›Jul 7, 2023approval1132d agoLEQVIO (INCLISIRAN SODIUM) — FDA approvalinclisiran

Sponsor: NOVARTIS. Form: SOLUTION. Route: SUBCUTANEOUS

full page →inclisiran →fda approvals ↗

Week of Jul 10, 2023

›Jul 10, 2023approval1129d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

›Jul 10, 2023approval

Week of Jul 17, 2023

›Jul 17, 2023approval1122d agoBEYFORTUS (NIRSEVIMAB-ALIP) — FDA approvalnirsevimab

Sponsor: ASTRAZENECA AB. Form: INJECTABLE. Route: INJECTION

full page →nirsevimab →fda approvals ↗

›Jul 17, 2023approval

Week of Jul 24, 2023

›Jul 24, 2023approval1115d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Jul 24, 2023approval

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page 4 of 499

1129d ago

XULTOPHY 100/3.6 (INSULIN DEGLUDEC) — FDA approvalNovo Nordisk Inc

Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

›Jul 11, 2023approval1128d agoHADLIMA (ADALIMUMAB-BWWD) — FDA approvalHADLIMA

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

full page →HADLIMA →fda approvals ↗

›Jul 12, 2023approval1127d agoAMJEVITA (ADALIMUMAB-ATTO) — FDA approvalAMJEVITA

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

full page →AMJEVITA →fda approvals ↗

›Jul 13, 2023approval1126d agoACETAMINOPHEN AND IBUPROFEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: GRANULES. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Jul 13, 2023approval1126d agoERTUGLIFLOZIN — FDA approvalERTUGLIFLOZIN

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

full page →ERTUGLIFLOZIN →fda approvals ↗

›Jul 13, 2023approval1126d agoVEKLURY (REMDESIVIR) — FDA approvalremdesivir

Sponsor: GILEAD SCIENCES INC. Form: SOLUTION. Route: INTRAVENOUS

full page →remdesivir →fda approvals ↗

›Jul 13, 2023approval1126d agoOPILL (NORGESTREL) — FDA approvalHRA Pharma LLC

Sponsor: LABORATOIRE HRA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Jul 14, 2023approval1125d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

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

full page →dupilumab →fda approvals ↗

1122d ago

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (FLUCONAZOLE) — FDA approvalDiflucan

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →Diflucan →fda approvals ↗

›Jul 17, 2023approval1122d agoFLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (FLUCONAZOLE) — FDA approvalDiflucan

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →Diflucan →fda approvals ↗

›Jul 17, 2023approval1122d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

Sponsor: LAURUS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Jul 17, 2023approval1122d agoMEPERIDINE HYDROCHLORIDE — FDA approvalHikma Pharmaceuticals Plc

Sponsor: BARR. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Jul 17, 2023approval1122d agoMEPERIDINE HYDROCHLORIDE — FDA approvalHikma Pharmaceuticals Plc

Sponsor: BARR. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Jul 17, 2023approval1122d agoMEPERIDINE HYDROCHLORIDE — FDA approvalHikma Pharmaceuticals Plc

Sponsor: BARR. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Jul 17, 2023approval1122d agoTEPEZZA (TEPROTUMUMAB-TRBW) — FDA approvalteprotumumab

Sponsor: HORIZON THERAPEUTICS IRELAND. Form: INJECTABLE. Route: INJECTION

full page →teprotumumab →fda approvals ↗

›Jul 18, 2023approval1121d agoABSORICA (ISOTRETINOIN) — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: SUN PHARM INDS INC. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Jul 18, 2023approval1121d agoABSORICA (ISOTRETINOIN) — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: SUN PHARM INDS INC. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Jul 18, 2023approval1121d agoABSORICA LD (ISOTRETINOIN) — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: SUN PHARM. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Jul 19, 2023approval1120d agoSILIQ (BRODALUMAB) — FDA approvalBausch Health US LLC

Sponsor: VALEANT LUXEMBOURG. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Jul 19, 2023approval1120d agoCYLTEZO (ADALIMUMAB-ADBM) — FDA approvalCYLTEZO

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

full page →CYLTEZO →fda approvals ↗

›Jul 20, 2023approval1119d agoVANFLYTA (QUIZARTINIB DIHYDROCHLORIDE) — FDA approvalquizartinib dihydrochloride

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

full page →quizartinib dihydrochloride →fda approvals ↗

›Jul 20, 2023approval1119d agoOTEZLA (APREMILAST) — FDA approvalapremilast

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

full page →apremilast →fda approvals ↗

›Jul 20, 2023approval1119d agoGAVRETO (PRALSETINIB) — FDA approvalRIGEL PHARMACEUTICALS INC

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

full page →fda approvals ↗

›Jul 20, 2023approval1119d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalAlembic Pharmaceuticals Inc

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

full page →fda approvals ↗

›Jul 20, 2023approval1119d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalMacleods Pharmaceuticals Ltd

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

full page →fda approvals ↗

›Jul 21, 2023approval1118d agoPREGABALIN — FDA approvalPREGABALIN

Sponsor: ESKAYEF. Form: CAPSULE. Route: ORAL

full page →PREGABALIN →fda approvals ↗

›Jul 21, 2023approval1118d agoWEGOVY (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

1115d ago

COSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Jul 24, 2023approval1115d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Jul 26, 2023approval1113d agoDOXYCYCLINE HYCLATE — FDA approvalPolyPid Ltd.