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23,383 catalysts · 5,000 device 510k · 4,728 grant · 3,778 approval · 3,086 8k filing · 2,000 device pma · 2,000 device recall

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  • device 510k5,000
  • grant4,728
  • approval3,778
  • 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 16, 2024

    14
    ›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 ↗

    Week of Sep 23, 2024

    36
    ›Sep 23, 2024approval688d agoTRUQAP (CAPIVASERTIB) — FDA approvalcapivasertib

    Sponsor: ASTRAZENECA. Form: TABLET. Route: ORAL

    full page →capivasertib →fda approvals ↗
    ›Sep 24, 2024approval
    ← prev
    page 5 of 468
    next →
    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 ↗
    ›Sep 27, 2024approval684d agoXELJANZ XR (TOFACITINIB CITRATE) — FDA approvaltofacitinib citrate ER

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

    full page →tofacitinib citrate ER →fda approvals ↗
    ›Sep 27, 2024approval684d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvalBiocon Pharma Ltd

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

    full page →fda approvals ↗
    ›Sep 27, 2024approval684d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvaltofacitinib citrate ER

    Sponsor: PFIZER. Form: SOLUTION. Route: ORAL

    full page →tofacitinib citrate ER →fda approvals ↗
    ›Sep 27, 2024approval684d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

    Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

    full page →UNASYN →fda approvals ↗
    ›Sep 27, 2024approval684d agoOTULFI (USTEKINUMAB-AAUZ) — FDA approvalOTULFI

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

    full page →OTULFI →fda approvals ↗
    ›Sep 27, 2024approval684d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

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

    full page →selpercatinib →fda approvals ↗
    ›Sep 27, 2024approval684d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

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

    full page →selpercatinib →fda approvals ↗
    ›Sep 27, 2024approval684d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

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

    full page →selpercatinib →fda approvals ↗
    ›Sep 27, 2024approval684d agoRETEVMO (SELPERCATINIB) — FDA approvalselpercatinib

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

    full page →selpercatinib →fda approvals ↗
    ›Sep 27, 2024device 510k684d agoHangzhou AllTest Biotech Co., Ltd. — AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel (510k cleared)Hangzhou DAC Biotech Co Ltd

    Product code: NFT. Advisory committee: Clinical Toxicology. Type: Traditional

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoWestridge Laboratories, Inc. — ID Free Personal Lubricant (510k cleared)G&W Laboratories Inc

    Product code: NUC. Advisory committee: Obstetrics/Gynecology. Type: Traditional

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoBrain Electrophysiology Laboratory Company, LLC — Sourcerer (510k cleared)

    Product code: OLX. Advisory committee: Neurology. Type: Traditional

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoShockwave Medical, Inc. — Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter (510k cleared)

    Product code: PPN. Advisory committee: Cardiovascular. Type: Traditional

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoO&M Halyard, Inc. — Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (510k cleared)Teva Pharmaceuticals USA Inc

    Product code: LZA. Advisory committee: General Hospital. Type: Abbreviated

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoNanosonics Limited — trophon Wireless Ultrasound Probe Holder (510k cleared)

    Product code: OUJ. Advisory committee: Radiology. Type: Traditional

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoOptmed, Inc. — TearRepair Liquid Skin Protectant (510k cleared)

    Product code: KMF. Advisory committee: General Hospital. Type: Traditional

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoResmed Corp — EasyCare Tx 2 (510k cleared)RESMED INC

    Product code: BZD. Advisory committee: Anesthesiology. Type: Traditional

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoChiaro Technology, Ltd. — Elvie Stride 2 (510k cleared)U-BX Technology Ltd.

    Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Special

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoIcare Finland OY — iCare ST500 (TA04) (510k cleared)

    Product code: HKY. Advisory committee: Ophthalmic. Type: Traditional

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoAit Austrian Institute of Technology GmbH — encevis (2.1) (510k cleared)

    Product code: OMB. Advisory committee: Neurology. Type: Traditional

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoDaeju Meditech Engineering Co., Ltd. — ACTIVO (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoAmc Health — AMC Health CareConsole (510k cleared)AOP Health

    Product code: MWI. Advisory committee: Cardiovascular. Type: Traditional

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoHyundae Meditech Co., Ltd. — Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162 FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW1938 (510k cleared)

    Product code: NEW. Advisory committee: General, Plastic Surgery. Type: Special

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoPi-Cardia, Ltd. — ShortCut (510k cleared)

    Product code: SCZ. Advisory committee: Cardiovascular. Type: Direct

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k684d agoBunkerHill Health — CAC (gated) Algorithm (510k cleared)

    Product code: JAK. Advisory committee: Radiology. Type: Traditional

    full page →fda device 510k ↗
    $IGC0.2670+0.41%
    $IGC0.2670+0.41%
    $AZN159.50-1.49%
    $PFE27.05+1.08%
    $REGN808.05+3.02%
    $AZN159.50-1.49%
    $TRVI17.66-0.79%
    $LLY1231.94+3.90%
    $LLY1231.94+3.90%
    $PFE27.05+1.08%
    $LLY1231.94+3.90%
    $LLY1231.94+3.90%
    $RMD220.38+5.13%
    $UBXG