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calendar

28,966 catalysts · 9,438 approval · 5,000 device 510k · 4,728 grant · 3,009 8k filing · 2,000 device pma · 2,000 device recall

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soonest latest type sponsor alpha

from 2017-11-21×clear all

type

approval9,438
device 510k5,000
grant4,728
8k filing3,009
device pma2,000
device recall2,000

recall

1,126

device adverse event1,000

earnings574

phase 2 completion172

therapy area

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

Week of Sep 6, 2021

›Sep 10, 2021approval1796d agoQDOLO (TRAMADOL HYDROCHLORIDE) — FDA approvaltramadol hydrochloride ER

Sponsor: ROSEMONT. Form: SOLUTION. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

›Sep 10, 2021approval1796d agoCONZIP (TRAMADOL HYDROCHLORIDE) — FDA approvalTrigen Laboratories Inc

Sponsor: CIPHER PHARMS INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Sep 10, 2021approval1796d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: STRIDES PHARMA INTL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

Week of Sep 13, 2021

›Sep 13, 2021approval1793d agoMETHADOSE (METHADONE HYDROCHLORIDE) — FDA approvalMETHADONE HYDROCHLORIDE

Sponsor: SPECGX LLC. Form: CONCENTRATE. Route: ORAL

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

›Sep 15, 2021approval

Week of Sep 20, 2021

›Sep 20, 2021approval1786d agoFLUOXETINE HYDROCHLORIDE — FDA approvalFLUOXETINE HYDROCHLORIDE

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

full page →FLUOXETINE HYDROCHLORIDE →fda approvals ↗

›Sep 20, 2021approval

Week of Sep 27, 2021

›Sep 27, 2021approval1779d agoHYCODAN (HOMATROPINE METHYLBROMIDE) — FDA approval

Sponsor: GENUS. Form: SYRUP. Route: ORAL

full page →fda approvals ↗

›Sep 28, 2021approval

Week of Oct 4, 2021

›Oct 4, 2021approval1772d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

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

full page →TRIKAFTA (COPACKAGED) →fda approvals ↗

›Oct 4, 2021approval

Week of Oct 11, 2021

›Oct 13, 2021approval1763d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

›Oct 13, 2021approval

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page 61 of 580

1791d ago

DALFAMPRIDINE — FDA approvalSolaxa Inc

Sponsor: ALKEM LABS LTD. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Sep 15, 2021approval1791d agoDALFAMPRIDINE — FDA approvalSolaxa Inc

Sponsor: ALKEM LABS LTD. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Sep 17, 2021approval1789d agoBYOOVIZ (RANIBIZUMAB-NUNA) — FDA approvalBYOOVIZ

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

full page →BYOOVIZ →fda approvals ↗

›Sep 17, 2021approval1789d agoCABOMETYX (CABOZANTINIB S-MALATE) — FDA approvalcabozantinib s-malate

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

full page →cabozantinib s-malate →fda approvals ↗

1786d ago

TIVDAK (TISOTUMAB VEDOTIN-TFTV) — FDA approvaltisotumab vedotin

Sponsor: SEAGEN. Form: INJECTABLE. Route: INJECTION

full page →tisotumab vedotin →fda approvals ↗

›Sep 21, 2021approval1785d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

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

full page →fda approvals ↗

›Sep 21, 2021approval1785d agoESCITALOPRAM OXALATE — FDA approvalAbbVie Inc.

Sponsor: SUN PHARMA CANADA. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

›Sep 22, 2021approval1784d agoSUBLOCADE (BUPRENORPHINE) — FDA approvalbuprenorphine LA

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

full page →buprenorphine LA →fda approvals ↗

›Sep 22, 2021approval1784d agoVINCRISTINE SULFATE PFS (VINCRISTINE SULFATE) — FDA approvalVINCRISTINE SULFATE PFS

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →VINCRISTINE SULFATE PFS →fda approvals ↗

›Sep 22, 2021approval1784d agoCOPIKTRA (DUVELISIB) — FDA approvalSecura Bio Inc

Sponsor: SECURA. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Sep 23, 2021approval1783d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: DEXCEL. Form: TABLET. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

›Sep 24, 2021approval1782d agoVYEPTI (EPTINEZUMAB-JJMR) — FDA approvalH. Lundbeck AS

Sponsor: Lundbeck Seattle BioPharmaceuticals, Inc.. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

1778d ago

QULIPTA (ATOGEPANT) — FDA approvalatogepant

Sponsor: ABBVIE. Form: TABLET. Route: ORAL

full page →atogepant →fda approvals ↗

›Sep 29, 2021approval1777d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: AUROBINDO PHARMA LTD. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

›Sep 29, 2021approval1777d agoADDYI (FLIBANSERIN) — FDA approvalSprout2 Inc

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

full page →fda approvals ↗

›Sep 30, 2021approval1776d agoTRULICITY (DULAGLUTIDE) — FDA approvaldulaglutide

Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: INJECTION

full page →dulaglutide →fda approvals ↗

›Sep 30, 2021approval1776d agoRUBRACA (RUCAPARIB CAMSYLATE) — FDA approvalrucaparib camsylate

Sponsor: PHARMAAND. Form: TABLET. Route: ORAL

full page →rucaparib camsylate →fda approvals ↗

›Oct 1, 2021approval1775d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

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

full page →dupilumab →fda approvals ↗

›Oct 1, 2021approval1775d agoSOGROYA (SOMAPACITAN-BECO) — FDA approvalsomatriptan albumin bound LA

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

full page →somatriptan albumin bound LA →fda approvals ↗

›Oct 1, 2021approval1775d agoSOGROYA (SOMAPACITAN-BECO) — FDA approvalsomatriptan albumin bound LA

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

full page →somatriptan albumin bound LA →fda approvals ↗

›Oct 1, 2021approval1775d agoONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE) — FDA approvalondansetron hydrochloride CR

Sponsor: ACCORD HLTHCARE. Form: INJECTABLE. Route: INJECTION

full page →ondansetron hydrochloride CR →fda approvals ↗

›Oct 1, 2021approval1775d agoONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE) — FDA approvalondansetron hydrochloride CR

Sponsor: ACCORD HLTHCARE. Form: INJECTABLE. Route: INJECTION

full page →ondansetron hydrochloride CR →fda approvals ↗

1772d ago

VENCLEXTA (VENETOCLAX) — FDA approvalvenetoclax

Sponsor: ABBVIE. Form: TABLET. Route: ORAL

full page →venetoclax →fda approvals ↗

›Oct 6, 2021approval1770d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

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

full page →atezolizumab →fda approvals ↗

›Oct 8, 2021approval1768d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: ACTAVIS LABS FL. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Oct 8, 2021approval1768d agoMYORISAN (ISOTRETINOIN) — FDA approvalSun Pharmaceutical Industries Ltd

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

full page →fda approvals ↗

›Oct 8, 2021approval1768d agoCLARAVIS (ISOTRETINOIN) — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

›Oct 8, 2021approval1768d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

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

full page →fda approvals ↗

›Oct 8, 2021approval1768d agoABSORICA (ISOTRETINOIN) — FDA approvalSun Pharmaceutical Industries Ltd

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

full page →fda approvals ↗

›Oct 8, 2021approval1768d agoAMNESTEEM (ISOTRETINOIN) — FDA approvalMylan Pharmaceuticals Inc

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

full page →fda approvals ↗

›Oct 8, 2021approval1768d agoCLARAVIS (ISOTRETINOIN) — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

›Oct 8, 2021approval1768d agoABSORICA LD (ISOTRETINOIN) — FDA approvalSun Pharmaceutical Industries Ltd

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

full page →fda approvals ↗

›Oct 8, 2021approval1768d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

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

full page →fda approvals ↗

›Oct 8, 2021approval1768d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

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

full page →fda approvals ↗

›Oct 8, 2021approval1768d agoZENATANE (ISOTRETINOIN) — FDA approvalISOTRETINOIN

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

full page →ISOTRETINOIN →fda approvals ↗

›Oct 8, 2021approval1768d agoALVIMOPAN — FDA approvalPar Pharmaceutical Inc

Sponsor: WATSON LABS TEVA. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

1763d ago

KEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

›Oct 13, 2021approval1763d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

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

full page →fda approvals ↗

›Oct 13, 2021approval1763d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

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

full page →fda approvals ↗

›Oct 13, 2021approval1763d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

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

full page →fda approvals ↗

›Oct 15, 2021approval1761d agoARSENIC TRIOXIDE — FDA approvalQuetzal Therapeutics LLC

Sponsor: EUGIA PHARMA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Oct 15, 2021approval1761d agoTECENTRIQ (ATEZOLIZUMAB) — FDA approvalatezolizumab

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

full page →atezolizumab →fda approvals ↗

$VERX11.94+3.20%

$INDV38.82+0.39%

$NVO47.26+2.81%

$REGN784.36+1.59%

$ABBV246.04+0.89%

$EXEL54.07+3.58%

$ABBV246.04+0.89%

$LLY1185.71-0.52%

$ABBV246.04+0.89%

$RDY12.22+0.91%