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9,401 catalysts · 3,230 8k filing · 2,032 grant · 1,000 device adverse event · 910 approval · 674 device 510k · 584 earnings

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  • 8k filing3,230
  • grant2,032
  • device adverse event1,000
  • approval910
  • device 510k674
  • earnings584
device pma
508
  • device recall215
  • phase 2 completion172
  • recall167
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Feb 16, 2026

    50
    ›Feb 17, 2026approval178d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

    Sponsor: ACS DOBFAR. Form: INJECTABLE. Route: INJECTION

    full page →UNASYN →fda approvals ↗
    ›Feb 17, 2026approval178d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

    Sponsor: ACS DOBFAR. Form: INJECTABLE. Route: INJECTION

    full page →UNASYN →fda approvals ↗
    ›Feb 17, 2026approval178d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

    Sponsor: ACS DOBFAR. Form: INJECTABLE. Route: INJECTION

    full page →UNASYN →fda approvals ↗
    ›Feb 17, 2026approval178d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

    Sponsor: ACS DOBFAR. Form: INJECTABLE. Route: INJECTION

    full page →UNASYN →fda approvals ↗
    ›Feb 17, 2026approval178d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

    Sponsor: ACS DOBFAR. Form: INJECTABLE. Route: INJECTION

    full page →UNASYN →fda approvals ↗
    ›Feb 17, 2026approval178d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

    Sponsor: ACS DOBFAR. Form: INJECTABLE. Route: INJECTION

    full page →UNASYN →fda approvals ↗
    ›Feb 17, 2026approval178d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

    full page →ALDACTAZIDE →fda approvals ↗
    ›Feb 17, 2026approval178d agoNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (ETHINYL ESTRADIOL) — FDA approvalNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

    Sponsor: APOTEX. Form: TABLET. Route: ORAL

    full page →NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE →fda approvals ↗
    ›Feb 17, 2026approval178d agoMETRONIDAZOLE — FDA approvalMETRONIDAZOLE

    Sponsor: ALEMBIC. Form: GEL. Route: TOPICAL

    full page →METRONIDAZOLE →fda approvals ↗
    ›Feb 17, 2026approval178d agoMETRONIDAZOLE — FDA approvalMETRONIDAZOLE

    Sponsor: ALEMBIC. Form: GEL. Route: TOPICAL

    full page →METRONIDAZOLE →fda approvals ↗
    ›Feb 17, 2026approval178d agoRELGAABI (GABAPENTIN) — FDA approvalSciegen Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Feb 17, 2026approval178d agoANAGRELIDE HYDROCHLORIDE — FDA approvalTakeda Pharmaceuticals USA Inc

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

    full page →fda approvals ↗
    ›Feb 17, 2026approval178d agoAMLODIPINE BESYLATE — FDA approvalGraviti Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›Feb 17, 2026approval178d agoMEROPENEM — FDA approvalMEROPENEM

    Sponsor: QILU. Form: INJECTABLE. Route: INJECTION

    full page →MEROPENEM →fda approvals ↗
    ›Feb 17, 2026device 510k178d agoBiomendex OY — Adaptos®Fuse Bone Graft (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 17, 2026device 510k178d agoLiquet Medical, Inc. — Versus™ Catheter (VS110-9NB) (510k cleared)

    Product code: QEY. Advisory committee: Cardiovascular. Type: Special

    full page →fda device 510k ↗
    ›Feb 17, 2026device 510k178d agoJiangsu Yuyue Medical Equipment & Supply Co., Ltd. — YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 17, 2026device 510k178d agoBiocomposites, Ltd. — Biosteon® Screw (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 17, 2026device 510k178d agoFujifilm Corporation — FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit (510k cleared)Fujifilm Holdings Corp

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

    full page →fda device 510k ↗
    ›Feb 17, 2026device 510k178d agoNingbo Shenyu Medical Equipment Co.,Ltd — Electric Wheelchair (W-A807, W-A807L) (510k cleared)

    Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional

    full page →fda device 510k ↗
    ›Feb 17, 2026device 510k178d agoCenterline Biomedical, Inc. — IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035) (510k cleared)

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

    full page →fda device 510k ↗
    ›Feb 17, 2026device pma178d agoMedtronic, Inc. — PulseSelect™ Pulsed Field Ablation (PFA) system (PMA supplement)Medtronic plc

    Supplement type: Normal 180 Day Track. Product code: QZI. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Feb 17, 2026device pma178d agoAlcon Research, LLC — UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LPO. Advisory committee: OP. Decision: OK30

    full page →fda device pma ↗
    ›Feb 17, 2026device pma178d agoEndotronix, Inc. — Cordella Pulmonary Artery Sensor System (CorPASS) (PMA supplement)

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

    full page →fda device pma ↗
    ›Feb 17, 2026device pma178d agoCooperVision, Inc. — MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (PMA supplement)

    Supplement type: 30-Day Notice. Product code: QIT. Advisory committee: OP. Decision: OK30

    full page →fda device pma ↗
    ›Feb 17, 2026device pma178d agoAlcon Research, LLC — UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LPO. Advisory committee: OP. Decision: OK30

    full page →fda device pma ↗
    ›Feb 17, 2026device recall178d agoMolded Products Inc device recall (Cls II)

    See Luer Cap Set, MPC-130, set, administration, intravascular — Reason: Molded Products, Inc. is voluntarily conducting a medical device recall of the MPC-130 See Luer Cap Set based on a confirmed complaint of the threaded sleeve not being engaged and becoming un-attached. — Status: Ongoing

    full page →fda device recalls ↗
    ›Feb 17, 2026grant178d agoCHILDREN'S HOSP OF PHILADELPHIA — Role of the PilC1 and PilC2 pilus-associated proteins in Kingella kingae path...PATH

    AI grant. $853,112. PI: Joseph W. St. Geme

    full page →nih reporter ↗
    ›Feb 17, 2026grant178d agoWASHINGTON STATE UNIVERSITY — Role of Fn-14 receptor in TNF-induced inflammation and tissue destruction

    AI grant. $497,779. PI: Salah-uddin Ahmed

    full page →nih reporter ↗
    ›Feb 17, 2026grant178d agoUNIVERSITY OF TEXAS DALLAS — Disruption of a DNA Repair Protein Promotes Antibiotic Resistance in Acinetob...

    AI grant. $434,625. PI: Nicholas A Dillon

    full page →nih reporter ↗
    ›Feb 17, 2026grant178d agoUNIVERSITY OF PENNSYLVANIA — The 22nd International Vasculitis WorkshopUniversity of Pennsylvania

    TR grant. $18,000. PI: Peter A Merkel

    full page →nih reporter ↗
    ›Feb 17, 2026grant178d agoUNIVERSITY OF CALIFORNIA-IRVINE — Vancomycin-Teixobactin Conjugates

    AI grant. $404,866. PI: JAMES S NOWICK

    full page →nih reporter ↗
    ›Feb 17, 2026grant178d agoDUKE UNIVERSITY — Identifying Endocrine-Disrupting Plastic Additives using Machine LearningDuke University

    ES grant. $444,125. PI: Daniel Reker

    full page →nih reporter ↗
    ›Feb 17, 2026grant178d agoJOHNS HOPKINS UNIVERSITY — Modification of the predisposition for ectopic calcificationJohns Hopkins University

    OD grant. $388,750. PI: Shira G Ziegler

    full page →nih reporter ↗
    ›Feb 17, 2026grant178d agoDUKE UNIVERSITY — Understanding environmental mitochondrial healthDuke University

    ES grant. $1,006,211. PI: Joel Newman Meyer

    full page →nih reporter ↗
    ›Feb 17, 2026grant178d agoJOHNS HOPKINS UNIVERSITY — Generating Critical Knowledge on the NMP Peptide Signaling in the Peripheral ...Johns Hopkins University

    NS grant. $232,938. PI: SETH S MARGOLIS

    full page →nih reporter ↗
    ›Feb 18, 2026approval177d agoTOFACITINIB CITRATE — FDA approvaltofacitinib citrate ER

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

    full page →tofacitinib citrate ER →fda approvals ↗
    ›Feb 18, 2026approval177d agoTOFACITINIB CITRATE — FDA approvaltofacitinib citrate ER

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

    full page →tofacitinib citrate ER →fda approvals ↗
    ›Feb 18, 2026approval177d agoTOFACITINIB CITRATE — FDA approvaltofacitinib citrate ER

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

    full page →tofacitinib citrate ER →fda approvals ↗
    ›Feb 18, 2026approval177d agoTOFACITINIB CITRATE — FDA approvaltofacitinib citrate ER

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

    full page →tofacitinib citrate ER →fda approvals ↗
    ›Feb 18, 2026approval177d agoTOFACITINIB CITRATE — FDA approvaltofacitinib citrate ER

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

    full page →tofacitinib citrate ER →fda approvals ↗
    ›Feb 18, 2026approval177d agoARBLI (LOSARTAN POTASSIUM) — FDA approvalLOSARTAN POTASSIUM

    Sponsor: SCIENTURE. Form: SUSPENSION. Route: ORAL

    full page →LOSARTAN POTASSIUM →fda approvals ↗
    ›Feb 18, 2026approval177d agoFINGOLIMOD HYDROCHLORIDE — FDA approvalEzra Ventures LLC

    Sponsor: CHARTWELL RX. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Feb 18, 2026approval177d agoFINGOLIMOD HYDROCHLORIDE — FDA approvalEzra Ventures LLC

    Sponsor: CHARTWELL RX. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Feb 18, 2026approval177d agoARIPIPRAZOLE — FDA approvalaripiprazole LA

    Sponsor: AUROBINDO PHARMA. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

    full page →aripiprazole LA →fda approvals ↗
    ›Feb 18, 2026approval177d agoEBANGA (ANSUVIMAB-ZYKL) — FDA approvalansuvimab

    Sponsor: RIDGEBACK BIOTHERAPEUTICS. Form: POWDER. Route: IV (INFUSION)

    full page →ansuvimab →fda approvals ↗
    ›Feb 18, 2026approval177d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

    Sponsor: IPCA LABS LTD. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Feb 18, 2026recall177d agoMcKesson recall (Cls I)MCKESSON CORP

    UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-63 — Reason: Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment. — Status: Ongoing

    full page →fda recalls ↗
    ›Feb 18, 2026recall177d agoF.H. INVESTMENTS, Inc. (dba Asteria Health) recall (Cls II)Transdermal Delivery Solutions Corp

    Testosterone, 100 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-1100-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing

    full page →fda recalls ↗
    ›Feb 18, 2026recall177d agoPro Numb Tattoo Numbing Spray LLC recall (Cls II)Sustained Therapeutics Inc

    Pro Numb Tattoo Numbing Spray, 5% Lidocaine, [1 FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-111-11 — Reason: cGMP deviations — Status: Ongoing

    full page →fda recalls ↗
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    $MCK862.63-1.83%
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