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calendar

7,545 catalysts · 4,728 grant · 3,203 device 510k · 3,183 8k filing · 2,817 approval · 2,000 device pma · 2,000 device recall

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type: approval×type: grant×from 2025-04-18×clear all

type

grant4,728
device 510k3,203
8k filing3,183
approval2,817
device pma2,000
device recall2,000

device adverse event

1,000

recall778

earnings584

phase 2 completion172

therapy area

no tagged catalysts yet

Week of Apr 14, 2025

›Apr 18, 2025approval482d agoWAINUA (AUTOINJECTOR) (EPLONTERSEN SODIUM) — FDA approvaleplontersen sodium

Sponsor: ASTRAZENECA AB. Form: SOLUTION. Route: SUBCUTANEOUS

full page →eplontersen sodium →fda approvals ↗

›Apr 18, 2025approval482d agoBKEMV (ECULIZUMAB-AEEB) — FDA approvaleculizumab biosimilar

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

full page →eculizumab biosimilar →fda approvals ↗

›Apr 18, 2025approval482d agoOJJAARA (MOMELOTINIB DIHYDROCHLORIDE) — FDA approvalmomelotinib dihydrochloride

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →momelotinib dihydrochloride →fda approvals ↗

›Apr 18, 2025approval482d agoSIMPONI (GOLIMUMAB) — FDA approvalJanssen Biotech Inc

Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Week of Apr 21, 2025

›Apr 21, 2025approval479d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

›Apr 21, 2025approval

Week of Apr 28, 2025

›Apr 28, 2025approval472d agoSPRAVATO (ESKETAMINE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗

›Apr 28, 2025approval

Week of May 5, 2025

›May 5, 2025approval465d agoTICAGRELOR — FDA approvalInvaGen Pharmaceuticals Inc

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

full page →fda approvals ↗

›May 5, 2025approval

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page 1 of 151

479d ago

MEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Spexotras →fda approvals ↗

›Apr 22, 2025approval478d agoTEVIMBRA (TISLELIZUMAB-JSGR) — FDA approvalBeOne Medicines Ltd.

Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION

full page →fda approvals ↗

›Apr 22, 2025approval478d agoTEVIMBRA (TISLELIZUMAB-JSGR) — FDA approvalBeOne Medicines Ltd.

Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION

full page →fda approvals ↗

›Apr 22, 2025approval478d agoTEVIMBRA (TISLELIZUMAB-JSGR) — FDA approvalBeOne Medicines Ltd.

Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION

full page →fda approvals ↗

›Apr 22, 2025approval478d agoTEVIMBRA (TISLELIZUMAB-JSGR) — FDA approvalBeOne Medicines Ltd.

Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION

full page →fda approvals ↗

›Apr 22, 2025approval478d agoTEVIMBRA (TISLELIZUMAB-JSGR) — FDA approvalBeOne Medicines Ltd.

Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION

full page →fda approvals ↗

›Apr 22, 2025approval478d agoTEVIMBRA (TISLELIZUMAB-JSGR) — FDA approvalBeOne Medicines Ltd.

Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION

full page →fda approvals ↗

›Apr 24, 2025approval476d agoALEVE (NAPROXEN SODIUM) — FDA approvalNAPROXEN SODIUM

Sponsor: BAYER. Form: TABLET. Route: ORAL

full page →NAPROXEN SODIUM →fda approvals ↗

›Apr 25, 2025approval475d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

›Apr 25, 2025approval475d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

›Apr 25, 2025approval475d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

›Apr 25, 2025approval475d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

›Apr 25, 2025approval475d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

›Apr 25, 2025approval475d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

›Apr 25, 2025approval475d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

›Apr 25, 2025approval475d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

472d ago

STEQEYMA (USTEKINUMAB-STBA) — FDA approvalSTEQEYMA

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

full page →STEQEYMA →fda approvals ↗

›Apr 28, 2025approval472d agoRINVOQ (UPADACITINIB) — FDA approvalupadacitinib tartrate ER

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

full page →upadacitinib tartrate ER →fda approvals ↗

›Apr 29, 2025approval471d agoDIVIGEL (ESTRADIOL) — FDA approvalVertical Pharmaceuticals LLC

Sponsor: VERTICAL PHARMS. Form: GEL. Route: TRANSDERMAL

full page →fda approvals ↗

›Apr 29, 2025approval471d agoBLINCYTO (BLINATUMOMAB) — FDA approvalblinatumomab

Sponsor: AMGEN. Form: INJECTABLE. Route: INJECTION

full page →blinatumomab →fda approvals ↗

›Apr 30, 2025approval470d agoZEPZELCA (LURBINECTEDIN) — FDA approvallurbinectedin

Sponsor: JAZZ. Form: POWDER. Route: INTRAVENOUS

full page →lurbinectedin →fda approvals ↗

›Apr 30, 2025approval470d agoEPYSQLI (ECULIZUMAB-AAGH) — FDA approvalEPYSQLI

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

full page →EPYSQLI →fda approvals ↗

›Apr 30, 2025approval470d agoOTULFI (USTEKINUMAB-AAUZ) — FDA approvalOTULFI

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

full page →OTULFI →fda approvals ↗

›Apr 30, 2025approval470d agoOTULFI (USTEKINUMAB-AAUZ) — FDA approvalOTULFI

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

full page →OTULFI →fda approvals ↗

›Apr 30, 2025approval470d agoYESINTEK (USTEKINUMAB-KFCE) — FDA approvalustekinumab biosimilar

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

full page →ustekinumab biosimilar →fda approvals ↗

›Apr 30, 2025approval470d agoPREGABALIN — FDA approvalInvaGen Pharmaceuticals Inc

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

full page →fda approvals ↗

›Apr 30, 2025approval470d agoBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

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

full page →BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE →fda approvals ↗

›Apr 30, 2025approval470d agoSTEQEYMA (USTEKINUMAB-STBA) — FDA approvalSTEQEYMA

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

full page →STEQEYMA →fda approvals ↗

›Apr 30, 2025approval470d agoSELARSDI (USTEKINUMAB-AEKN) — FDA approvalAlvotech

Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Apr 30, 2025approval470d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

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

full page →PYZCHIVA →fda approvals ↗

›Apr 30, 2025approval470d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

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

full page →PYZCHIVA →fda approvals ↗

›Apr 30, 2025approval470d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

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

full page →PYZCHIVA →fda approvals ↗

›May 1, 2025approval469d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

Sponsor: ABBVIE. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL

full page →divalproex sodium DR →fda approvals ↗

›May 1, 2025approval469d agoDEPAKOTE ER (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗

›May 1, 2025approval469d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

Sponsor: ABBVIE. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →divalproex sodium DR →fda approvals ↗

›May 1, 2025approval469d agoTEVIMBRA (TISLELIZUMAB-JSGR) — FDA approvalBeOne Medicines Ltd.

Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION

full page →fda approvals ↗

›May 1, 2025approval469d agoTICAGRELOR — FDA approvalTICAGRELOR

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →TICAGRELOR →fda approvals ↗

›May 2, 2025approval468d agoTICAGRELOR — FDA approvalTICAGRELOR

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

full page →TICAGRELOR →fda approvals ↗

465d ago

FENSOLVI KIT (LEUPROLIDE ACETATE) — FDA approvalLEUPROLIDE ACETATE

Sponsor: TOLMAR. Form: POWDER. Route: SUBCUTANEOUS

full page →LEUPROLIDE ACETATE →fda approvals ↗

›May 6, 2025approval464d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

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

full page →tramadol hydrochloride ER →fda approvals ↗

›May 7, 2025approval463d agoSKYRIZI (RISANKIZUMAB-RZAA) — FDA approvalrisankizumab

Sponsor: ABBVIE INC. Form: INJECTABLE. Route: INTRAVENOUS

full page →risankizumab →fda approvals ↗

›May 7, 2025approval463d agoSKYRIZI (RISANKIZUMAB-RZAA) — FDA approvalrisankizumab

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

full page →risankizumab →fda approvals ↗

›May 9, 2025approval461d agoBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalNovitium Pharma LLC

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

full page →fda approvals ↗

$AZN157.56-0.75%

$AMGN416.31+0.48%

$NVS152.51-1.35%

$ONC357.81-0.41%

$AMGN416.31+0.48%

$ONC357.81-0.41%

$ABBV248.14-0.78%

$JAZZ249.85+0.75%

$HCWB

$ALVO4.0100+5.53%

$ABBV248.14-0.78%

$ONC357.81-0.41%

$ABBV248.14-0.78%