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17,936 catalysts · 4,728 grant · 3,603 8k filing · 2,587 approval · 1,933 device 510k · 1,543 device recall · 1,343 device pma

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  • grant4,728
  • 8k filing3,603
  • approval2,587
  • device 510k1,933
  • device recall1,543
  • device pma1,343
  • device adverse event1,000
  • earnings585
  • recall534
  • phase 2 completion172
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Sep 22, 2025

    50
    ›Sep 26, 2025approval338d agoFLUOXETINE HYDROCHLORIDE — FDA approvalEli Lilly and Co

    Sponsor: INVENTIA HLTHCARE. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Sep 26, 2025approval338d agoFLUOXETINE HYDROCHLORIDE — FDA approvalEli Lilly and Co

    Sponsor: INVENTIA HLTHCARE. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Sep 26, 2025approval338d agoAMPHETAMINE SULFATE — FDA approvalamfetamine ER

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

    full page →amfetamine ER →fda approvals ↗
    ›Sep 26, 2025approval338d agoPYRIDOSTIGMINE BROMIDE — FDA approvalBausch Health US LLC

    Sponsor: US ARMY. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Sep 26, 2025approval338d agoOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

    Sponsor: MSN. Form: TABLET. Route: ORAL

    full page →ALDACTAZIDE →fda approvals ↗
    ›Sep 26, 2025approval338d agoCAFFEINE CITRATE — FDA approvalCAFFEINE CITRATE

    Sponsor: FRESENIUS KABI USA. Form: SOLUTION. Route: ORAL

    full page →CAFFEINE CITRATE →fda approvals ↗
    ›Sep 26, 2025approval338d agoCELECOXIB — FDA approvalScilex Holding Co

    Sponsor: NANJING. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Sep 26, 2025approval338d agoCELECOXIB — FDA approvalScilex Holding Co

    Sponsor: NANJING. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Sep 26, 2025approval338d agoCELECOXIB — FDA approvalScilex Holding Co

    Sponsor: NANJING. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Sep 26, 2025approval338d agoTIZANIDINE HYDROCHLORIDE — FDA approvalRiconpharma LLC

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

    full page →fda approvals ↗
    ›Sep 26, 2025approval338d agoLIDOCAINE HYDROCHLORIDE — FDA approvalLaryng-O-Jet

    Sponsor: COSETTE. Form: JELLY. Route: TOPICAL

    full page →Laryng-O-Jet →fda approvals ↗
    ›Sep 26, 2025approval338d agoAMPHETAMINE SULFATE — FDA approvalAmneal Pharmaceuticals, Inc.

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

    full page →fda approvals ↗
    ›Sep 26, 2025approval338d agoTREMFYA (GUSELKUMAB) — FDA approvalguselkumab

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

    full page →guselkumab →fda approvals ↗
    ›Sep 26, 2025approval338d agoTREMFYA (GUSELKUMAB) — FDA approvalguselkumab

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

    full page →guselkumab →fda approvals ↗
    ›Sep 26, 2025approval338d agoQVAR REDIHALER (BECLOMETHASONE DIPROPIONATE) — FDA approvalSOLIGENIX, INC.

    Sponsor: NORTON WATERFORD. Form: AEROSOL, METERED. Route: INHALATION

    full page →fda approvals ↗
    ›Sep 26, 2025approval338d agoCALCITONIN-SALMON (CALCITONIN SALMON) — FDA approvalcalcitonin

    Sponsor: AMNEAL. Form: INJECTABLE. Route: INJECTION

    full page →calcitonin →fda approvals ↗
    ›Sep 26, 2025approval338d agoAMPHETAMINE SULFATE — FDA approvalAurolife Pharma LLC

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

    full page →fda approvals ↗
    ›Sep 26, 2025approval338d agoAMPHETAMINE SULFATE — FDA approvalamfetamine ER

    Sponsor: GRANULES. Form: TABLET. Route: ORAL

    full page →amfetamine ER →fda approvals ↗
    ›Sep 26, 2025approval338d agoCLOTIC (CLOTRIMAZOLE) — FDA approvalSun Pharmaceutical Industries Ltd

    Sponsor: CARWIN PHARM ASSOC. Form: SOLUTION/DROPS. Route: OTIC

    full page →fda approvals ↗
    ›Sep 26, 2025approval338d agoULTOMIRIS (RAVULIZUMAB-CWVZ) — FDA approvalAlexion Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Sep 26, 2025approval338d agoTACROLIMUS — FDA approvaltacrolimus ER

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

    full page →tacrolimus ER →fda approvals ↗
    ›Sep 26, 2025approval338d agoTACROLIMUS — FDA approvaltacrolimus ER

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

    full page →tacrolimus ER →fda approvals ↗
    ›Sep 26, 2025approval338d agoXPOVIO (SELINEXOR) — FDA approvalselinexor

    Sponsor: KARYOPHARM THERAPS. Form: TABLET. Route: ORAL

    full page →selinexor →fda approvals ↗
    ›Sep 26, 2025approval338d agoVORICONAZOLE — FDA approvalVORICONAZOLE

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

    full page →VORICONAZOLE →fda approvals ↗
    ›Sep 26, 2025approval338d agoACETYLCYSTEINE — FDA approvalACETYLCYSTEINE

    Sponsor: SOMERSET THERAPS LLC. Form: SOLUTION. Route: INHALATION, ORAL

    full page →ACETYLCYSTEINE →fda approvals ↗
    ›Sep 26, 2025approval338d agoDICLOFENAC SODIUM — FDA approvalHisamitsu Pharmaceutical Co Inc

    Sponsor: ENCUBE. Form: GEL. Route: TOPICAL

    full page →fda approvals ↗
    ›Sep 26, 2025approval338d agoAMPHETAMINE SULFATE — FDA approvalAurolife Pharma LLC

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

    full page →fda approvals ↗
    ›Sep 26, 2025device 510k338d agoBoston Scientific Corporation — Radial Jaw 4 Pulmonary Biopsy Forceps (510k cleared)BOSTON SCIENTIFIC CORP

    Product code: BWH. Advisory committee: Ear, Nose, Throat. Type: Special

    full page →fda device 510k ↗
    ›Sep 26, 2025device 510k338d agoCanon Medical Systems Corporation — Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 26, 2025device 510k338d agoBalt USA, LLC — Optima Coil System (Optima Packing Coil System) (510k cleared)Bayer USA LLC

    Product code: HCG. Advisory committee: Neurology. Type: Special

    full page →fda device 510k ↗
    ›Sep 26, 2025device 510k338d agoFUJIFILM Healthcare Americas Corporation — FUJIFILM Stiffening Wire Device (SW-2000) (510k cleared)

    Product code: FDA. Advisory committee: Gastroenterology, Urology. Type: Traditional

    full page →fda device 510k ↗
    ›Sep 26, 2025device 510k338d agoCaretaker Medical — VitalStream ART Connect; VitalStream-Hemo (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 26, 2025device 510k338d agoShoulder Innovations, Inc. — Inset Reverse Total Shoulder System (510k cleared)SHOULDER INNOVATIONS, INC.

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

    full page →fda device 510k ↗
    ›Sep 26, 2025device 510k338d agoOlympus Medical Systems Corporation — AUXILIARY WATER TUBE MAJ-855 (510k cleared)

    Product code: OCX. Advisory committee: Gastroenterology, Urology. Type: Traditional

    full page →fda device 510k ↗
    ›Sep 26, 2025device 510k338d agoLevita Magnetics International Corp — Magnetic Surgical System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 26, 2025device 510k338d agoPlanmed OY — Planmed XFI (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 26, 2025device 510k338d agoNanjing Bestview Laser S&T Co., Ltd. — Thulium Laser System (Deluxlase) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 26, 2025device 510k338d agoS.I.N. Implant System Ltda — S.I.N. Dental Implant System (510k cleared)

    Product code: DZE. Advisory committee: Dental. Type: Traditional

    full page →fda device 510k ↗
    ›Sep 26, 2025device 510k338d agoLigence Uab — Ligence Heart (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 26, 2025device 510k338d agoLinshom Medical, Inc. — Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 26, 2025device 510k338d agoWellspect AB — LoFric Origo (510k cleared)

    Product code: EZD. Advisory committee: Gastroenterology, Urology. Type: Traditional

    full page →fda device 510k ↗
    ›Sep 26, 2025device 510k338d agoTuned , Ltd. — Tuned Self-Fitting Mobile App (510k cleared)

    Product code: SCR. Advisory committee: Ear, Nose, Throat. Type: Traditional

    full page →fda device 510k ↗
    ›Sep 26, 2025device pma338d agoCochlear Americas — Nucleus® 24 Cochlear Implant System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MCM. Advisory committee: EN. Decision: OK30

    full page →fda device pma ↗
    ›Sep 26, 2025device pma338d agoABBOTT MEDICAL — Infinity™ DBS System (PMA supplement)

    Supplement type: Real-Time Process. Product code: MHY. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Sep 26, 2025device pma338d agoABBOTT MEDICAL — Proclaim™ SCS System (PMA supplement)

    Supplement type: Real-Time Process. Product code: LGW. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Sep 26, 2025device pma338d agoMedtronic Vascular, Inc. — VenaSeal Closure System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: PJQ. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Sep 26, 2025device pma338d agoQ-Med AB — Restylane® Injectable Gel (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30

    full page →fda device pma ↗
    ›Sep 26, 2025device pma338d agoABBOTT MEDICAL — Proclaim™ DRG System (PMA supplement)

    Supplement type: Real-Time Process. Product code: PMP. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Sep 26, 2025device pma338d agoDepuy, Inc. — LCS® Total Knee System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NJL. Advisory committee: OR. Decision: OK30

    full page →fda device pma ↗
    ›Sep 26, 2025device pma338d agoABBOTT MEDICAL — Esprit™ BTK Everolimus Eluting Resorbable Scaffold System (PMA supplement)Postsurgical Therapeutics Inc

    Supplement type: 30-Day Notice. Product code: NXW. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ← prev
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    $AMRX17.54-2.61%
    $SNGX
    $BSX46.84+0.36%
    $SCLX8.8000+25.00%
    $KPTI
    $SCLX8.8000+25.00%
    $AMRX17.54-2.61%
    $SCLX8.8000+25.00%
    $SI