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calendar

7,898 catalysts · 4,728 grant · 4,294 device 510k · 3,606 8k filing · 3,170 approval · 2,000 device pma · 2,000 device recall

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type: approval×type: grant×from 2024-12-13×clear all

type

grant4,728
device 510k4,294
8k filing3,606
approval3,170
device pma2,000
device recall2,000

recall

1,027

device adverse event1,000

earnings585

phase 2 completion172

therapy area

no tagged catalysts yet

Week of Dec 9, 2024

›Dec 13, 2024approval$VERX14.22-0.52%627d agoORKAMBI (IVACAFTOR) — FDA approval(ivacaftor + lumacaftor)

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

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

›Dec 13, 2024approval627d agoORKAMBI (IVACAFTOR) — FDA approval(ivacaftor + lumacaftor)

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

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

›Dec 13, 2024approval627d agoTYENNE (TOCILIZUMAB-AAZG) — FDA approvalTYENNE

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

full page →TYENNE →fda approvals ↗

›Dec 13, 2024approval627d agoUNLOXCYT (COSIBELIMAB-IPDL) — FDA approvalcosibelimab

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

full page →cosibelimab →fda approvals ↗

Week of Dec 16, 2024

›Dec 16, 2024approval624d agoDEPO-SUBQ PROVERA 104 (MEDROXYPROGESTERONE ACETATE) — FDA approvalmedroxyprogesterone acetate

Sponsor: PFIZER. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →medroxyprogesterone acetate →fda approvals ↗

›Dec 17, 2024approval

Week of Dec 23, 2024

›Dec 23, 2024approval617d agoYUFLYMA (ADALIMUMAB-AATY) — FDA approvalYUFLYMA

Sponsor: CELLTRION. Form: INJECTABLE. Route: INJECTION

full page →YUFLYMA →fda approvals ↗

›Dec 26, 2024approval

Week of Dec 30, 2024

›Dec 30, 2024approval610d agoREZUROCK (BELUMOSUDIL MESYLATE) — FDA approvalbelumosudil mesylate

Sponsor: KADMON PHARMS LLC. Form: TABLET. Route: ORAL

full page →belumosudil mesylate →fda approvals ↗

›Dec 31, 2024approval

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page 1 of 158

623d ago

GABAPENTIN — FDA approvalAlmatica Pharma LLC

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

full page →fda approvals ↗

›Dec 17, 2024approval623d agoVIGABATRIN — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

›Dec 17, 2024approval623d agoVIGABATRIN — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

›Dec 17, 2024approval623d agoSTEQEYMA (USTEKINUMAB-STBA) — FDA approvalSTEQEYMA

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

full page →STEQEYMA →fda approvals ↗

›Dec 17, 2024approval623d agoBLINCYTO (BLINATUMOMAB) — FDA approvalblinatumomab

Sponsor: AMGEN. Form: INJECTABLE. Route: INJECTION

full page →blinatumomab →fda approvals ↗

›Dec 18, 2024approval622d agoENSACOVE (ENSARTINIB HYDROCHLORIDE) — FDA approvalensartinib hydrochloride

Sponsor: XCOVERY. Form: CAPSULE. Route: ORAL

full page →ensartinib hydrochloride →fda approvals ↗

›Dec 18, 2024approval622d agoIDACIO (ADALIMUMAB-AACF) — FDA approvalIDACIO

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

full page →IDACIO →fda approvals ↗

›Dec 18, 2024approval622d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

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

full page →selpercatinib →fda approvals ↗

›Dec 18, 2024approval622d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

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

full page →selpercatinib →fda approvals ↗

›Dec 19, 2024approval621d agoGABAPENTIN — FDA approvalGABAPENTIN

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

full page →GABAPENTIN →fda approvals ↗

›Dec 19, 2024approval621d agoGABAPENTIN — FDA approvalGABAPENTIN

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

full page →GABAPENTIN →fda approvals ↗

›Dec 19, 2024approval621d agoGABAPENTIN — FDA approvalGABAPENTIN

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

full page →GABAPENTIN →fda approvals ↗

›Dec 19, 2024approval621d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

Sponsor: ALKEM. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Dec 19, 2024approval621d agoCEREZYME (IMIGLUCERASE) — FDA approvalimiglucerase

Sponsor: GENZYME. Form: INJECTABLE. Route: INJECTION

full page →imiglucerase →fda approvals ↗

›Dec 19, 2024approval621d agoGABAPENTIN — FDA approvalGABAPENTIN

Sponsor: SANDOZ. Form: CAPSULE. Route: ORAL

full page →GABAPENTIN →fda approvals ↗

›Dec 19, 2024approval621d agoVEKLURY (REMDESIVIR) — FDA approvalremdesivir

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

full page →remdesivir →fda approvals ↗

›Dec 20, 2024approval620d agoSKYCLARYS (OMAVELOXOLONE) — FDA approvalReata Pharmaceuticals Inc

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

full page →fda approvals ↗

›Dec 20, 2024approval620d agoSKYCLARYS (OMAVELOXOLONE) — FDA approvalReata Pharmaceuticals Inc

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

full page →fda approvals ↗

›Dec 20, 2024approval620d 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, 2024approval620d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

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

full page →TRIKAFTA (COPACKAGED) →fda approvals ↗

›Dec 20, 2024approval620d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

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

full page →TRIKAFTA (COPACKAGED) →fda approvals ↗

›Dec 20, 2024approval620d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

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

full page →TRIKAFTA (COPACKAGED) →fda approvals ↗

›Dec 20, 2024approval620d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

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

full page →TRIKAFTA (COPACKAGED) →fda approvals ↗

›Dec 20, 2024approval620d agoIMCIVREE (SETMELANOTIDE ACETATE) — FDA approvalsetmelanotide

Sponsor: RHYTHM. Form: SOLUTION. Route: SUBCUTANEOUS

full page →setmelanotide →fda approvals ↗

›Dec 20, 2024approval620d agoZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →ZEPBOUND →fda approvals ↗

›Dec 20, 2024approval620d agoBRAFTOVI (ENCORAFENIB) — FDA approvalencorafenib

Sponsor: ARRAY BIOPHARMA INC. Form: CAPSULE. Route: ORAL

full page →encorafenib →fda approvals ↗

›Dec 20, 2024approval620d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

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

full page →PYZCHIVA →fda approvals ↗

›Dec 20, 2024approval620d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

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

full page →PYZCHIVA →fda approvals ↗

›Dec 20, 2024approval620d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

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

full page →PYZCHIVA →fda approvals ↗

›Dec 20, 2024approval620d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

Sponsor: PHARMACYCLICS LLC. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Dec 20, 2024approval620d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

Sponsor: PHARMACYCLICS LLC. Form: SUSPENSION. Route: ORAL

full page →fda approvals ↗

›Dec 20, 2024approval620d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

Sponsor: PHARMACYCLICS LLC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

614d ago

EBANGA (ANSUVIMAB-ZYKL) — FDA approvalansuvimab

Sponsor: RIDGEBACK BIOTHERAPEUTICS. Form: POWDER. Route: IV (INFUSION)

full page →ansuvimab →fda approvals ↗

›Dec 26, 2024approval614d agoWEZLANA (USTEKINUMAB-AUUB) — FDA approvalWEZLANA

Sponsor: AMGEN INC. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS

full page →WEZLANA →fda approvals ↗

›Dec 26, 2024approval614d agoWEZLANA (USTEKINUMAB-AUUB) — FDA approvalWEZLANA

Sponsor: AMGEN INC. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS

full page →WEZLANA →fda approvals ↗

›Dec 27, 2024approval613d agoOPDIVO QVANTIG (NIVOLUMAB) — FDA approval(hyaluronidase (recombinant, human) + nivolumab)

Sponsor: BRISTOL-MYERS SQUIBB. Form: INJECTABLE. Route: SUBCUTANEOUS

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

609d ago

SPRAVATO (ESKETAMINE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL

full page →fda approvals ↗

›Dec 31, 2024approval609d agoGABAPENTIN — FDA approvalSciegen Pharmaceuticals Inc

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

full page →fda approvals ↗

›Dec 31, 2024approval609d agoGABAPENTIN — FDA approvalSciegen Pharmaceuticals Inc

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

full page →fda approvals ↗

›Dec 31, 2024approval609d agoGABAPENTIN — FDA approvalSciegen Pharmaceuticals Inc

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

full page →fda approvals ↗

›Dec 31, 2024approval609d agoRELGAABI (GABAPENTIN) — FDA approvalSciegen Pharmaceuticals Inc

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

full page →fda approvals ↗

›Dec 31, 2024approval609d agoRELGAABI (GABAPENTIN) — FDA approvalSciegen Pharmaceuticals Inc

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

full page →fda approvals ↗

›Dec 31, 2024approval609d agoRELGAABI (GABAPENTIN) — FDA approvalSciegen Pharmaceuticals Inc

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

full page →fda approvals ↗

$VERX14.22-0.52%

$CCCC

$PFE27.96-0.21%

$AMRX17.54-2.61%

$AMGN432.42-1.05%

$LLY1174.61-0.13%

$VERX14.22-0.52%

$RYTM107.17-4.76%

$GILD145.68-2.14%

$LLY1174.61-0.13%

$VERX14.22-0.52%

$BMY66.58-0.55%

$AVBP30.17-2.68%

$VERX14.22-0.52%

$ABBV255.48-1.03%

$AMGN432.42-1.05%

$ABBV255.48-1.03%

$AMGN432.42-1.05%