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calendar

3,191 catalysts · 4,728 grant · 4,410 device 510k · 3,350 8k filing · 3,191 approval · 2,000 device pma · 2,000 device recall

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soonest latest type sponsor alpha

type: approval×from 2024-11-29×clear all

type

grant4,728
device 510k4,410
8k filing3,350
approval3,191
device pma2,000
device recall2,000
recall

1,078

device adverse event1,000

earnings584

phase 2 completion172

therapy area

no tagged catalysts yet

Week of Nov 25, 2024

›Nov 29, 2024approval625d agoYESINTEK (USTEKINUMAB-KFCE) — FDA approvalustekinumab biosimilar

Sponsor: BIOCON BIOLOGICS INC. Form: INJECTABLE. Route: INJECTION

full page →ustekinumab biosimilar →fda approvals ↗

›Nov 29, 2024approval625d agoDAYTRANA (METHYLPHENIDATE) — FDA approvalNoven Pharmaceuticals Inc

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

full page →fda approvals ↗

›Nov 29, 2024approval625d agoXELSTRYM (DEXTROAMPHETAMINE) — FDA approvalNoven Pharmaceuticals Inc

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

full page →fda approvals ↗

Week of Dec 2, 2024

›Dec 2, 2024approval622d agoTECVAYLI (TECLISTAMAB-CQYV) — FDA approvalteclistamab

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

full page →teclistamab →fda approvals ↗

›Dec 2, 2024approval

Week of Dec 9, 2024

›Dec 9, 2024approval615d agoOZEMPIC (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Dec 9, 2024approval

Week of Dec 16, 2024

›Dec 16, 2024approval608d agoDEPO-SUBQ PROVERA 104 (MEDROXYPROGESTERONE ACETATE) — FDA approvalmedroxyprogesterone acetate

Sponsor: PFIZER. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →medroxyprogesterone acetate →fda approvals ↗

›Dec 17, 2024approval

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page 1 of 64

622d ago

TALVEY (TALQUETAMAB-TGVS) — FDA approvaltalquetamab

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

full page →talquetamab →fda approvals ↗

›Dec 2, 2024approval622d agoAXTLE (PEMETREXED DIPOTASSIUM) — FDA approvalAXTLE

Sponsor: AVYXA HOLDINGS. Form: POWDER. Route: INTRAVENOUS

full page →AXTLE →fda approvals ↗

›Dec 3, 2024approval621d agoBOSULIF (BOSUTINIB MONOHYDRATE) — FDA approvalAlembic Pharmaceuticals Inc

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

full page →fda approvals ↗

›Dec 3, 2024approval621d agoBOSULIF (BOSUTINIB MONOHYDRATE) — FDA approvalAlembic Pharmaceuticals Inc

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

full page →fda approvals ↗

›Dec 3, 2024approval621d agoVABOMERE (MEROPENEM) — FDA approvalHQ Speciality Pharma

Sponsor: REMPEX. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

›Dec 3, 2024approval621d agoTYENNE (TOCILIZUMAB-AAZG) — FDA approvalTYENNE

Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INTRAVENOUS

full page →TYENNE →fda approvals ↗

›Dec 4, 2024approval620d agoIMFINZI (DURVALUMAB) — FDA approvalASTRAZENECA PLC

Sponsor: ASTRAZENECA UK LTD. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Dec 6, 2024approval618d agoISOVUE-250 (IOPAMIDOL) — FDA approval

Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

615d ago

OZEMPIC (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

Sponsor: NOVO. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Dec 9, 2024approval615d agoERTUGLIFLOZIN — FDA approvalERTUGLIFLOZIN

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

full page →ERTUGLIFLOZIN →fda approvals ↗

›Dec 9, 2024approval615d agoPREGABALIN — FDA approvalPREGABALIN

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

full page →PREGABALIN →fda approvals ↗

›Dec 10, 2024approval614d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

full page →tocilizumab →fda approvals ↗

›Dec 10, 2024approval614d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

Sponsor: GENENTECH. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS

full page →tocilizumab →fda approvals ↗

›Dec 10, 2024approval614d agoHEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (HEPARIN SODIUM) — FDA approvalHEPARIN SODIUM

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →HEPARIN SODIUM →fda approvals ↗

›Dec 11, 2024approval613d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

›Dec 12, 2024approval612d agoNURTEC ODT (RIMEGEPANT SULFATE) — FDA approvalrimegepant sulfate ODT

Sponsor: PFIZER. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →rimegepant sulfate ODT →fda approvals ↗

›Dec 13, 2024approval611d agoORKAMBI (IVACAFTOR) — FDA approval(ivacaftor + lumacaftor)

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

full page →(ivacaftor + lumacaftor) →fda approvals ↗

›Dec 13, 2024approval611d agoORKAMBI (IVACAFTOR) — FDA approval(ivacaftor + lumacaftor)

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

full page →(ivacaftor + lumacaftor) →fda approvals ↗

›Dec 13, 2024approval611d agoTYENNE (TOCILIZUMAB-AAZG) — FDA approvalTYENNE

Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INTRAVENOUS

full page →TYENNE →fda approvals ↗

›Dec 13, 2024approval611d agoUNLOXCYT (COSIBELIMAB-IPDL) — FDA approvalcosibelimab

Sponsor: CHECKPOINT THERAPEUTICS INC. Form: INJECTABLE. Route: INJECTION

full page →cosibelimab →fda approvals ↗

607d ago

GABAPENTIN — FDA approvalAlmatica Pharma LLC

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

full page →fda approvals ↗

›Dec 17, 2024approval607d agoVIGABATRIN — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

›Dec 17, 2024approval607d agoVIGABATRIN — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

›Dec 17, 2024approval607d agoSTEQEYMA (USTEKINUMAB-STBA) — FDA approvalSTEQEYMA

Sponsor: CELLTRION, INC.. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →STEQEYMA →fda approvals ↗

›Dec 17, 2024approval607d agoBLINCYTO (BLINATUMOMAB) — FDA approvalblinatumomab

Sponsor: AMGEN. Form: INJECTABLE. Route: INJECTION

full page →blinatumomab →fda approvals ↗

›Dec 18, 2024approval606d agoENSACOVE (ENSARTINIB HYDROCHLORIDE) — FDA approvalensartinib hydrochloride

Sponsor: XCOVERY. Form: CAPSULE. Route: ORAL

full page →ensartinib hydrochloride →fda approvals ↗

›Dec 18, 2024approval606d agoIDACIO (ADALIMUMAB-AACF) — FDA approvalIDACIO

Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →IDACIO →fda approvals ↗

›Dec 18, 2024approval606d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

Sponsor: ELI LILLY AND CO. Form: CAPSULE. Route: ORAL

full page →selpercatinib →fda approvals ↗

›Dec 18, 2024approval606d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

Sponsor: ELI LILLY AND CO. Form: CAPSULE. Route: ORAL

full page →selpercatinib →fda approvals ↗

›Dec 19, 2024approval605d agoGABAPENTIN — FDA approvalGABAPENTIN

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

full page →GABAPENTIN →fda approvals ↗

›Dec 19, 2024approval605d agoGABAPENTIN — FDA approvalGABAPENTIN

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

full page →GABAPENTIN →fda approvals ↗

›Dec 19, 2024approval605d agoGABAPENTIN — FDA approvalGABAPENTIN

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

full page →GABAPENTIN →fda approvals ↗

›Dec 19, 2024approval605d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

Sponsor: ALKEM. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Dec 19, 2024approval605d agoCEREZYME (IMIGLUCERASE) — FDA approvalimiglucerase

Sponsor: GENZYME. Form: INJECTABLE. Route: INJECTION

full page →imiglucerase →fda approvals ↗

›Dec 19, 2024approval605d agoGABAPENTIN — FDA approvalGABAPENTIN

Sponsor: SANDOZ. Form: CAPSULE. Route: ORAL

full page →GABAPENTIN →fda approvals ↗

›Dec 19, 2024approval605d agoVEKLURY (REMDESIVIR) — FDA approvalremdesivir

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

full page →remdesivir →fda approvals ↗

›Dec 20, 2024approval604d agoSKYCLARYS (OMAVELOXOLONE) — FDA approvalReata Pharmaceuticals Inc

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

full page →fda approvals ↗

›Dec 20, 2024approval604d agoSKYCLARYS (OMAVELOXOLONE) — FDA approvalReata Pharmaceuticals Inc

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

full page →fda approvals ↗

›Dec 20, 2024approval604d agoALYFTREK (DEUTIVACAFTOR) — FDA approval(deutivacaftor + tezacaftor + vanzacaftor calcium)

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

full page →(deutivacaftor + tezacaftor + vanzacaftor calcium) →fda approvals ↗

›Dec 20, 2024approval604d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

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

full page →TRIKAFTA (COPACKAGED) →fda approvals ↗

›Dec 20, 2024approval604d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

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

full page →TRIKAFTA (COPACKAGED) →fda approvals ↗

›Dec 20, 2024approval604d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

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

full page →TRIKAFTA (COPACKAGED) →fda approvals ↗

›Dec 20, 2024approval604d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

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

full page →TRIKAFTA (COPACKAGED) →fda approvals ↗

›Dec 20, 2024approval604d agoIMCIVREE (SETMELANOTIDE ACETATE) — FDA approvalsetmelanotide

Sponsor: RHYTHM. Form: SOLUTION. Route: SUBCUTANEOUS

full page →setmelanotide →fda approvals ↗

$HCWB

$PFE26.79-0.04%

$VERX12.72-4.00%

$PFE26.79-0.04%

$VERX12.72-4.00%

$AZN156.45-0.50%

$LLY1180.16-2.25%

$AMGN415.21-0.63%

$LLY1180.16-2.25%

$AMRX18.15+5.10%

$CCCC

$VERX12.72-4.00%

$GILD138.36+0.16%

$VERX12.72-4.00%

$RYTM115.48-0.47%