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calendar

29,088 catalysts · 9,524 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

from 2017-08-31×clear all

type

approval9,524
device 510k5,000
grant4,728
8k filing3,045
device pma2,000
device recall2,000

recall

1,126

device adverse event1,000

earnings577

phase 2 completion172

therapy area

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

Week of Jun 14, 2021

›Jun 17, 2021approval1881d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

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

full page →RIFADIN →fda approvals ↗

›Jun 17, 2021approval1881d agoASTEPRO ALLERGY (AZELASTINE HYDROCHLORIDE) — FDA approvalWallace Pharmaceuticals Inc

Sponsor: BAYER HLTHCARE. Form: SPRAY, METERED. Route: NASAL

full page →fda approvals ↗

›Jun 17, 2021approval1881d agoZOLADEX (GOSERELIN ACETATE) — FDA approvalgoserelin LA

Sponsor: TERSERA. Form: IMPLANT. Route: IMPLANTATION

full page →goserelin LA →fda approvals ↗

›Jun 17, 2021approval1881d agoZOLADEX (GOSERELIN ACETATE) — FDA approvalgoserelin LA

Sponsor: TERSERA. Form: IMPLANT. Route: IMPLANTATION

full page →goserelin LA →fda approvals ↗

Week of Jun 21, 2021

›Jun 21, 2021approval1877d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗

›Jun 21, 2021approval

Week of Jun 28, 2021

›Jun 28, 2021approval1870d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

›Jun 28, 2021approval

Week of Jul 5, 2021

›Jul 6, 2021approval1862d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗

›Jul 7, 2021approval

Week of Jul 12, 2021

›Jul 13, 2021approval1855d agoBACLOFEN — FDA approvalBACLOFEN

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

full page →BACLOFEN →fda approvals ↗

›Jul 14, 2021approval

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page 60 of 582

1877d ago

METHYLPHENIDATE HYDROCHLORIDE — FDA approvalMETHYLPHENIDATE HYDROCHLORIDE

Sponsor: ABHAI LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →METHYLPHENIDATE HYDROCHLORIDE →fda approvals ↗

›Jun 21, 2021approval1877d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalMETHYLPHENIDATE HYDROCHLORIDE

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

full page →METHYLPHENIDATE HYDROCHLORIDE →fda approvals ↗

›Jun 22, 2021approval1876d agoBIJUVA (ESTRADIOL) — FDA approval(estradiol + progesterone)

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

full page →(estradiol + progesterone) →fda approvals ↗

›Jun 22, 2021approval1876d agoBIJUVA (ESTRADIOL) — FDA approval(estradiol + progesterone)

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

full page →(estradiol + progesterone) →fda approvals ↗

›Jun 25, 2021approval1873d agoCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Jun 25, 2021approval1873d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalMETHYLPHENIDATE HYDROCHLORIDE

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

full page →METHYLPHENIDATE HYDROCHLORIDE →fda approvals ↗

›Jun 25, 2021approval1873d agoQUILLICHEW ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: NEXTWAVE PHARMS. Form: TABLET, EXTENDED RELEASE, CHEWABLE. Route: ORAL

full page →fda approvals ↗

›Jun 25, 2021approval1873d agoQUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: NEXTWAVE. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Jun 25, 2021approval1873d agoTEMOZOLOMIDE — FDA approvalAreva Pharmaceuticals Inc

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

full page →fda approvals ↗

›Jun 25, 2021approval1873d agoTEMOZOLOMIDE — FDA approvalAreva Pharmaceuticals Inc

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

full page →fda approvals ↗

›Jun 25, 2021approval1873d agoMETHYLIN ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETHYLIN ER

Sponsor: SPECGX LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →METHYLIN ER →fda approvals ↗

›Jun 25, 2021approval1873d agoMETADATE ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETADATE ER

Sponsor: LANNETT CO INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →METADATE ER →fda approvals ↗

›Jun 25, 2021approval1873d agoMETADATE ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETADATE ER

Sponsor: LANNETT CO INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →METADATE ER →fda approvals ↗

›Jun 25, 2021approval1873d agoJORNAY PM (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: IRONSHORE PHARMS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Jun 25, 2021approval1873d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalMETHYLPHENIDATE HYDROCHLORIDE

Sponsor: ABHAI LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →METHYLPHENIDATE HYDROCHLORIDE →fda approvals ↗

›Jun 25, 2021approval1873d agoDAYTRANA (METHYLPHENIDATE) — FDA approvalNoven Pharmaceuticals Inc

Sponsor: NOVEN PHARMS INC. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →fda approvals ↗

›Jun 25, 2021approval1873d agoMETADATE CD (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETADATE CD

Sponsor: AYTU BIOPHARMA. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →METADATE CD →fda approvals ↗

›Jun 25, 2021approval1873d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

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

full page →fda approvals ↗

›Jun 25, 2021approval1873d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalMETHYLPHENIDATE HYDROCHLORIDE

Sponsor: HERITAGE PHARMA. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →METHYLPHENIDATE HYDROCHLORIDE →fda approvals ↗

›Jun 25, 2021approval1873d agoAPTENSIO XR (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: RHODES PHARMS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Jun 25, 2021approval1873d agoCOTEMPLA XR-ODT (METHYLPHENIDATE) — FDA approvalAYTU BIOPHARMA, INC

Sponsor: NEOS THERAPS INC. Form: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

›Jun 26, 2021approval1872d agoFOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) — FDA approvaldexmethylphenidate hydrochloride ER

Sponsor: SANDOZ. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →dexmethylphenidate hydrochloride ER →fda approvals ↗

›Jun 26, 2021approval1872d agoRITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalRITALIN LA

Sponsor: SANDOZ. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →RITALIN LA →fda approvals ↗

1870d ago

METHYLPHENIDATE HYDROCHLORIDE — FDA approvalMETHYLPHENIDATE HYDROCHLORIDE

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

full page →METHYLPHENIDATE HYDROCHLORIDE →fda approvals ↗

›Jun 29, 2021approval1869d agoDAPTOMYCIN — FDA approvalDaptomycin Novo

Sponsor: MEITHEAL. Form: POWDER. Route: INTRAVENOUS

full page →Daptomycin Novo →fda approvals ↗

›Jun 29, 2021approval1869d agoDAPTOMYCIN — FDA approvalDaptomycin Novo

Sponsor: MEITHEAL. Form: POWDER. Route: INTRAVENOUS

full page →Daptomycin Novo →fda approvals ↗

›Jun 30, 2021approval1868d agoTOPAMAX SPRINKLE (TOPIRAMATE) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗

›Jun 30, 2021approval1868d agoTOPAMAX (TOPIRAMATE) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗

›Jul 1, 2021approval1867d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

1861d ago

OMEPRAZOLE — FDA approvalomeprazole DR

Sponsor: DEXCEL. Form: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE. Route: ORAL

full page →omeprazole DR →fda approvals ↗

›Jul 7, 2021approval1861d agoOMEPRAZOLE — FDA approvalomeprazole DR

Sponsor: DEXCEL PHARMA. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →omeprazole DR →fda approvals ↗

›Jul 7, 2021approval1861d agoDESIPRAMINE HYDROCHLORIDE — FDA approvalDESIPRAMINE HYDROCHLORIDE

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

full page →DESIPRAMINE HYDROCHLORIDE →fda approvals ↗

›Jul 8, 2021approval1860d agoPOTELIGEO (MOGAMULIZUMAB-KPKC) — FDA approvalmogamulizumab

Sponsor: KYOWA KIRIN. Form: INJECTABLE. Route: INJECTION

full page →mogamulizumab →fda approvals ↗

›Jul 8, 2021approval1860d agoWELLBUTRIN XL (BUPROPION HYDROCHLORIDE) — FDA approvalIpca Pharmaceuticals Inc

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

full page →fda approvals ↗

›Jul 8, 2021approval1860d agoAPLENZIN (BUPROPION HYDROBROMIDE) — FDA approvalBausch Health US LLC

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

full page →fda approvals ↗

›Jul 9, 2021approval1859d agoDARZALEX FASPRO (DARATUMUMAB AND HYALURONIDASE-FIHJ) — FDA approval(daratumumab + hyaluronidase (human recombinant))

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

full page →(daratumumab + hyaluronidase (human recombinant)) →fda approvals ↗

›Jul 9, 2021approval1859d agoPADCEV (ENFORTUMAB VEDOTIN-EJFV) — FDA approvalenfortumab vedotin

Sponsor: ASTELLAS. Form: INJECTABLE. Route: INJECTION

full page →enfortumab vedotin →fda approvals ↗

›Jul 9, 2021approval1859d agoPADCEV (ENFORTUMAB VEDOTIN-EJFV) — FDA approvalenfortumab vedotin

Sponsor: ASTELLAS. Form: INJECTABLE. Route: INJECTION

full page →enfortumab vedotin →fda approvals ↗

›Jul 9, 2021approval1859d agoTIVICAY (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

Sponsor: VIIV HLTHCARE. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Jul 9, 2021approval1859d agoTIVICAY PD (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

Sponsor: VIIV HLTHCARE. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗

›Jul 9, 2021approval1859d agoJULUCA (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

Sponsor: VIIV HLTHCARE. Form: TABLET. Route: ORAL

full page →fda approvals ↗

1854d ago

ERLEADA (APALUTAMIDE) — FDA approvalapalutamide

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

full page →apalutamide →fda approvals ↗

$COLL27.20-7.70%

$AYTU2.2300-0.89%

$COLL27.20-7.70%

$AYTU2.2300-0.89%

$COLL27.20-7.70%