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calendar

23,663 catalysts · 5,000 device 510k · 4,728 grant · 3,955 approval · 3,189 8k filing · 2,000 device pma · 2,000 device recall

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soonest latest type sponsor alpha

from 2024-04-10×clear all

type

device 510k5,000
grant4,728
approval3,955
8k filing3,189
device pma2,000
device recall2,000

recall

1,126

device adverse event1,000

earnings584

phase 2 completion172

therapy area

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

Week of Aug 19, 2024

›Aug 22, 2024approval721d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

›Aug 22, 2024approval721d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

›Aug 22, 2024approval721d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Week of Aug 26, 2024

›Aug 26, 2024approval717d agoDOXYCYCLINE — FDA approvaldoxycycline ER

Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

full page →doxycycline ER →fda approvals ↗

›Aug 26, 2024approval

Week of Sep 2, 2024

›Sep 4, 2024approval708d agoTRILEPTAL (OXCARBAZEPINE) — FDA approvalOXCARBAZEPINE

Sponsor: NOVARTIS. Form: SUSPENSION. Route: ORAL

full page →OXCARBAZEPINE →fda approvals ↗

›Sep 4, 2024approval

Week of Sep 9, 2024

›Sep 9, 2024approval703d agoGABAPENTIN — FDA approvalGABAPENTIN

Sponsor: RISING. Form: CAPSULE. Route: ORAL

full page →GABAPENTIN →fda approvals ↗

›Sep 9, 2024approval

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page 7 of 474

717d ago

DOXYCYCLINE — FDA approvaldoxycycline ER

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

full page →doxycycline ER →fda approvals ↗

›Aug 26, 2024approval717d agoDOXYCYCLINE — FDA approvaldoxycycline ER

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

full page →doxycycline ER →fda approvals ↗

›Aug 26, 2024approval717d agoDOXYCYCLINE — FDA approvaldoxycycline ER

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

full page →doxycycline ER →fda approvals ↗

›Aug 26, 2024approval717d agoDOXYCYCLINE — FDA approvaldoxycycline ER

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

full page →doxycycline ER →fda approvals ↗

›Aug 26, 2024approval717d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

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

full page →fda approvals ↗

›Aug 26, 2024approval717d agoSIMLANDI (ADALIMUMAB-RYVK) — FDA approvalAlvotech

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

full page →fda approvals ↗

›Aug 26, 2024approval717d agoSIMLANDI (ADALIMUMAB-RYVK) — FDA approvalAlvotech

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

full page →fda approvals ↗

›Aug 27, 2024approval716d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

Sponsor: HOSPIRA. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗

›Aug 27, 2024approval716d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

Sponsor: HOSPIRA. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗

›Aug 27, 2024approval716d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

Sponsor: HOSPIRA. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗

›Aug 27, 2024approval716d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

Sponsor: HOSPIRA. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗

›Aug 28, 2024approval715d agoACTIQ (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: CEPHALON. Form: TROCHE/LOZENGE. Route: TRANSMUCOSAL

full page →fda approvals ↗

›Aug 28, 2024approval715d agoFENTORA (FENTANYL CITRATE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: CEPHALON. Form: TABLET. Route: BUCCAL, SUBLINGUAL

full page →fda approvals ↗

›Aug 30, 2024approval713d agoSEVOFLURANE — FDA approvalSEVOFLURANE

Sponsor: BAXTER HLTHCARE. Form: LIQUID. Route: INHALATION

full page →SEVOFLURANE →fda approvals ↗

708d ago

TRILEPTAL (OXCARBAZEPINE) — FDA approvalOXCARBAZEPINE

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →OXCARBAZEPINE →fda approvals ↗

›Sep 5, 2024approval707d agoFILSPARI (SPARSENTAN) — FDA approvalsparsentan

Sponsor: TRAVERE. Form: TABLET. Route: ORAL

full page →sparsentan →fda approvals ↗

›Sep 5, 2024approval707d agoTYENNE (TOCILIZUMAB-AAZG) — FDA approvalTYENNE

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

full page →TYENNE →fda approvals ↗

›Sep 5, 2024approval707d agoROXYBOND (OXYCODONE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

›Sep 6, 2024approval706d agoNICARDIPINE HYDROCHLORIDE — FDA approvalNICARDIPINE HYDROCHLORIDE

Sponsor: CHENGDU SHUODE. Form: INJECTABLE. Route: INJECTION

full page →NICARDIPINE HYDROCHLORIDE →fda approvals ↗

703d ago

RISPERIDONE — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

›Sep 10, 2024approval702d agoELREXFIO (ELRANATAMAB) — FDA approvalelranatamab

Sponsor: PFIZER INC. Form: SOLUTION. Route: INJECTION

full page →elranatamab →fda approvals ↗

›Sep 11, 2024approval701d agoALEVE (NAPROXEN SODIUM) — FDA approvalNAPROXEN SODIUM

Sponsor: BAYER. Form: TABLET. Route: ORAL

full page →NAPROXEN SODIUM →fda approvals ↗

›Sep 11, 2024approval701d agoTREMFYA (GUSELKUMAB) — FDA approvalguselkumab

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

full page →guselkumab →fda approvals ↗

›Sep 12, 2024approval700d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

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

full page →dupilumab →fda approvals ↗

›Sep 12, 2024approval700d agoVIGABATRIN — FDA approvalPyros Pharmaceuticals Inc.

Sponsor: PH HEALTH. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗

›Sep 12, 2024approval700d agoVIGABATRIN — FDA approvalVIGABATRIN

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

full page →VIGABATRIN →fda approvals ↗

›Sep 12, 2024approval700d agoVIGABATRIN — FDA approvalPyros Pharmaceuticals Inc.

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

full page →fda approvals ↗

›Sep 12, 2024approval700d agoVIGABATRIN — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

›Sep 12, 2024approval700d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: ACCORD HLTHCARE. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

›Sep 12, 2024approval700d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: ZYDUS LIFESCIENCES. Form: TABLET. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

›Sep 12, 2024approval700d agoSABRIL (VIGABATRIN) — FDA approvalVIGABATRIN

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

full page →VIGABATRIN →fda approvals ↗

›Sep 12, 2024approval700d agoVIGABATRIN — FDA approvalPyros Pharmaceuticals Inc.

Sponsor: DR REDDYS. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗

›Sep 12, 2024approval700d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: MSN. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

›Sep 12, 2024approval700d agoVIGABATRIN — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗

›Sep 12, 2024approval700d agoVIGABATRIN — FDA approvalTeva Pharmaceuticals USA Inc

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

full page →fda approvals ↗

›Sep 12, 2024approval700d agoVIGABATRIN — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗

›Sep 12, 2024approval700d agoVIGABATRIN — FDA approvalPyros Pharmaceuticals Inc.

Sponsor: DR REDDYS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Sep 12, 2024approval700d agoVIGPODER (VIGABATRIN) — FDA approvalPyros Pharmaceuticals Inc.

Sponsor: PYROS PHARMS. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗

›Sep 12, 2024approval700d agoSABRIL (VIGABATRIN) — FDA approvalVIGABATRIN

Sponsor: LUNDBECK PHARMS LLC. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

›Sep 12, 2024approval700d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: DEXCEL. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

›Sep 12, 2024approval700d agoVIGABATRIN — FDA approvalPyros Pharmaceuticals Inc.

Sponsor: ALKEM LABS LTD. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗

›Sep 12, 2024approval700d agoVIGADRONE (VIGABATRIN) — FDA approvalVIGABATRIN

Sponsor: AUCTA. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

›Sep 12, 2024approval700d agoVIGABATRIN — FDA approvalInvaGen Pharmaceuticals Inc

Sponsor: INVAGEN PHARMS. Form: FOR SOLUTION. Route: ORAL

full page →fda approvals ↗

›Sep 12, 2024approval700d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: CARNEGIE. Form: TABLET. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

$NVS152.32-1.48%

$AMRX17.52+2.43%

$NVS152.32-1.48%

$ALVO4.0100+5.53%

$PFE26.31-1.16%

$TVTX62.16+3.24%

$ALVO4.0100+5.53%

$AMRX17.52+2.43%

$REGN799.43+0.30%

$AMRX17.52+2.43%