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calendar

23,358 catalysts · 5,000 device 510k · 4,728 grant · 3,753 approval · 3,086 8k filing · 2,000 device pma · 2,000 device recall

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soonest latest type sponsor alpha

from 2024-07-08×clear all

type

device 510k5,000
grant4,728
approval3,753
8k filing3,086
device pma2,000
device recall2,000

recall

1,126

device adverse event1,000

earnings583

phase 2 completion172

therapy area

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

Week of Sep 9, 2024

›Sep 12, 2024approval699d agoVIGABATRIN — FDA approvalVIGABATRIN

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

full page →VIGABATRIN →fda approvals ↗

›Sep 12, 2024approval699d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: DEXCEL. Form: TABLET. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

›Sep 12, 2024approval699d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

›Sep 12, 2024approval699d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: AUROBINDO PHARMA LTD. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗

›Sep 12, 2024approval699d agoMETHOTREXATE — FDA approvalMaxtrex

Sponsor: ACCORD HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS

full page →Maxtrex →fda approvals ↗

›Sep 12, 2024approval699d agoBRAFTOVI (ENCORAFENIB) — FDA approvalencorafenib

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

full page →encorafenib →fda approvals ↗

›Sep 12, 2024approval699d agoPAXLOVID (COPACKAGED) (NIRMATRELVIR) — FDA approvalPAXLOVID (COPACKAGED)

Sponsor: PFIZER. Form: TABLET. Route: ORAL

full page →PAXLOVID (COPACKAGED) →fda approvals ↗

›Sep 12, 2024approval699d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

Sponsor: IMMUNEX. Form: SYRINGE

full page →fda approvals ↗

›Sep 12, 2024approval699d agoTECENTRIQ HYBREZA (ATEZOLIZUMAB AND HYALURONIDASE-TQJS) — FDA approval(atezolizumab + hyaluronidase (human recombinant))

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

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

›Sep 13, 2024approval698d agoPROCHLORPERAZINE EDISYLATE — FDA approvalPROCHLORPERAZINE EDISYLATE

Sponsor: SOMERSET THERAPS LLC. Form: INJECTABLE. Route: INJECTION

full page →PROCHLORPERAZINE EDISYLATE →fda approvals ↗

›Sep 13, 2024approval698d agoQSYMIA (PHENTERMINE HYDROCHLORIDE) — FDA approval(phentermine hydrochloride + topiramate) ER

Sponsor: VIVUS LLC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →(phentermine hydrochloride + topiramate) ER →fda approvals ↗

›Sep 13, 2024approval698d agoEBGLYSS (LEBRIKIZUMAB-LBKZ) — FDA approvallebrikizumab

Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: INJECTION

full page →lebrikizumab →fda approvals ↗

›Sep 13, 2024approval698d agoCIMZIA (CERTOLIZUMAB PEGOL) — FDA approvalcertolizumab pegol

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

full page →certolizumab pegol →fda approvals ↗

Week of Sep 16, 2024

›Sep 17, 2024approval694d agoBOSENTAN — FDA approvalBOSENTAN

Sponsor: WATSON LABS INC. Form: TABLET. Route: ORAL

full page →BOSENTAN →fda approvals ↗

›Sep 17, 2024approval

Week of Sep 23, 2024

›Sep 23, 2024approval688d agoTRUQAP (CAPIVASERTIB) — FDA approvalcapivasertib

Sponsor: ASTRAZENECA. Form: TABLET. Route: ORAL

full page →capivasertib →fda approvals ↗

›Sep 24, 2024approval

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page 4 of 468

694d ago

BOSENTAN — FDA approvalZydus Therapeutics Inc

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

full page →fda approvals ↗

›Sep 17, 2024approval694d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

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

full page →pembrolizumab →fda approvals ↗

›Sep 17, 2024approval694d agoBOSENTAN — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

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

full page →fda approvals ↗

›Sep 17, 2024approval694d agoBOSENTAN — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

›Sep 17, 2024approval694d agoBOSENTAN — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

Sponsor: PH HEALTH. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Sep 17, 2024approval694d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

Sponsor: ACTELION. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Sep 17, 2024approval694d agoBOSENTAN — FDA approvalBOSENTAN

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

full page →BOSENTAN →fda approvals ↗

›Sep 17, 2024approval694d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

Sponsor: ACTELION. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗

›Sep 17, 2024approval694d agoEVRYSDI (RISDIPLAM) — FDA approvalEVRYSDI

Sponsor: GENENTECH INC. Form: FOR SOLUTION. Route: ORAL

full page →EVRYSDI →fda approvals ↗

›Sep 19, 2024approval692d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: SANALUZ. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Sep 19, 2024approval692d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: EPIC PHARMA LLC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Sep 19, 2024approval692d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: SANKALP LIFECARE. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

›Sep 19, 2024approval692d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: SANKALP LIFECARE. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

›Sep 19, 2024approval692d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

Sponsor: SOMERSET THERAPS LLC. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗

›Sep 19, 2024approval692d agoNALBUPHINE HYDROCHLORIDE — FDA approvalNALBUPHINE HYDROCHLORIDE

Sponsor: SOMERSET THERAPS LLC. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

full page →NALBUPHINE HYDROCHLORIDE →fda approvals ↗

›Sep 19, 2024approval692d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

full page →tocilizumab →fda approvals ↗

›Sep 19, 2024approval692d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

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

full page →tocilizumab →fda approvals ↗

›Sep 19, 2024approval692d agoPYLERA (BISMUTH SUBCITRATE POTASSIUM) — FDA approval

Sponsor: LABS JUVISE. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Sep 19, 2024approval692d agoRYBREVANT (AMIVANTAMAB-VMJW) — FDA approvalamivantamab

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

full page →amivantamab →fda approvals ↗

›Sep 19, 2024approval692d agoKINERET (ANAKINRA) — FDA approvalSobi Inc

Sponsor: BIOVITRUM AB. Form: VIAL. Route: SUBCUTANEOUS

full page →fda approvals ↗

›Sep 19, 2024approval692d agoULTOMIRIS (RAVULIZUMAB-CWVZ) — FDA approvalAlexion Pharmaceuticals Inc

Sponsor: ALEXION PHARM. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Sep 20, 2024approval691d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

full page →tocilizumab →fda approvals ↗

›Sep 20, 2024approval691d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

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

full page →tocilizumab →fda approvals ↗

›Sep 20, 2024approval691d agoCABENUVA KIT (CABOTEGRAVIR) — FDA approvalViiV Healthcare Company

Sponsor: VIIV HLTHCARE. Form: SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →fda approvals ↗

›Sep 20, 2024approval691d agoDIAMOX (ACETAZOLAMIDE) — FDA approvalAccord Healthcare Inc

Sponsor: TEVA BRANDED PHARM. Form: TABLET. Route: ORAL

full page →fda approvals ↗

687d ago

FLUOROURACIL — FDA approvalExtrovis AG

Sponsor: KINDOS. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Sep 25, 2024approval686d agoWAINUA (AUTOINJECTOR) (EPLONTERSEN SODIUM) — FDA approvaleplontersen sodium

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

full page →eplontersen sodium →fda approvals ↗

›Sep 26, 2024approval685d agoMYCOPHENOLATE MOFETIL — FDA approvalMYCOPHENOLATE MOFETIL

Sponsor: AUROBINDO PHARMA LTD. Form: FOR SUSPENSION. Route: ORAL

full page →MYCOPHENOLATE MOFETIL →fda approvals ↗

›Sep 26, 2024approval685d agoPOMALIDOMIDE — FDA approvalPOMALIDOMIDE

Sponsor: HETERO LABS LTD V. Form: CAPSULE. Route: ORAL

full page →POMALIDOMIDE →fda approvals ↗

›Sep 26, 2024approval685d agoNALBUPHINE HYDROCHLORIDE — FDA approvalTrevi Therapeutics, Inc.

Sponsor: DR REDDYS. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

full page →fda approvals ↗

›Sep 26, 2024device 510k685d agoAccelerate Diagnostics, Inc. — Accelerate Arc System (510k cleared)

Product code: QNJ. Advisory committee: Microbiology. Type: Traditional

full page →fda device 510k ↗

›Sep 26, 2024device 510k685d agoMolli Surgical, Inc. — MOLLI 2 System (510k cleared)

Product code: NEU. Advisory committee: General, Plastic Surgery. Type: Traditional

full page →fda device 510k ↗

›Sep 26, 2024device 510k685d agoSpineguard — Cannulated PsiFGuard (510k cleared)

Product code: SCY. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗

›Sep 27, 2024approval684d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

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

full page →dupilumab →fda approvals ↗

›Sep 27, 2024approval684d agoALENDRONATE SODIUM — FDA approvalALENDRONATE SODIUM

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

full page →ALENDRONATE SODIUM →fda approvals ↗

$AVBP30.99+0.49%

$PFE27.05+1.08%

$AMGN417.20+1.52%

$LLY1231.94+3.90%

$AZN161.91+0.30%

$IGC0.2670+0.41%

$AZN161.91+0.30%

$IGC0.2670+0.41%

$TRVI17.80-3.84%

$AMRX17.47-2.29%

$REGN808.05+3.02%

$NSRX2.7000-1.82%