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calendar

5,854 catalysts · 18,987 approval · 5,347 phase readout · 5,000 device 510k · 4,728 grant · 2,580 8k filing · 2,000 device pma

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  • approval18,987
  • phase readout5,347
  • device 510k5,000
  • grant4,728
  • 8k filing2,580
  • device pma2,000
  • device recall
2,000
  • recall1,126
  • device adverse event1,000
  • pdufa347
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    no tagged catalysts yet

    Week of Sep 8, 2025

    50
    ›Sep 9, 2025grant326d agoCARE4QOL LLC — Empowering Direct Care Workers with AI-Integrated Wearable Technology to Prev...

    NR grant. $306,817. PI: YUCHI YOUNG

    full page →nih reporter ↗
    ›Sep 9, 2025grant326d agoMASSACHUSETTS GENERAL HOSPITAL — Capacity Building for the Diagnosis and Treatment of Neuromyelitis Optica usi...Massachusetts General Hospital

    TW grant. $1. PI: Farrah Jasmine Mateen

    full page →nih reporter ↗
    ›Sep 9, 2025grant326d agoARIZONA STATE UNIVERSITY-TEMPE CAMPUS — Glyco-MAP: a high-throughput multiplexed platform for Glycosylated Mucin Anti...

    CA grant. $183,494. PI: Ji Qiu

    full page →nih reporter ↗
    ›Sep 9, 2025grant326d agoVIRGINIA POLYTECHNIC INST AND ST UNIV — Leveraging Mexican Millipede Secretions as Neuromodulators

    TW grant. $375,392. PI: Emily Elizabeth Mevers

    full page →nih reporter ↗
    ›Sep 9, 2025grant326d agoUNIVERSITY OF CALIFORNIA, SAN FRANCISCO — UZ-UCSF CTUUniversity of California San Francisco

    AI grant. $873,804. PI: ZVAVAHERA MIKE CHIRENJE

    full page →nih reporter ↗
    ›Sep 9, 2025grant326d agoUNIVERSITY OF PENNSYLVANIA — Mapping the gene regulatory architecture of pancreatic islet-specific cell ty...University of Pennsylvania

    DK grant. $787,367. PI: Kyle Jeffrie Gaulton

    full page →nih reporter ↗
    ›Sep 10, 2025recall325d agoBoothwyn Pharmacy LLC recall (Cls II)Novo Nordisk AS

    Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy — Reason: Subpotent Drug — Status: Ongoing

    full page →fda recalls ↗
    ›Sep 10, 2025recall325d agoDermaRite Industries, LLC recall (Cls I)

    PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08 — Reason: Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia. — Status: Ongoing

    full page →fda recalls ↗
    ›Sep 10, 2025recall325d agoB BRAUN MEDICAL INC recall (Cls I)B. Braun Medical Inc

    0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09 — Reason: Presence of Particulate Matter. — Status: Ongoing

    full page →fda recalls ↗
    ›Sep 10, 2025recall325d agoDermaRite Industries, LLC recall (Cls I)

    DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08 — Reason: Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia. — Status: Ongoing

    full page →fda recalls ↗
    ›Sep 10, 2025recall325d agoBoothwyn Pharmacy LLC recall (Cls III)

    Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496 — Reason: Subpotent Drug — Status: Ongoing

    full page →fda recalls ↗
    ›Sep 10, 2025recall325d agoAmneal Pharmaceuticals, LLC recall (Cls II)Amneal Pharmaceuticals, Inc.

    chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1062-1. — Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. — Status: Ongoing

    full page →fda recalls ↗
    ›Sep 10, 2025recall325d agoAmneal Pharmaceuticals, LLC recall (Cls II)Amneal Pharmaceuticals, Inc.

    chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1060-1. — Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. — Status: Ongoing

    full page →fda recalls ↗
    ›Sep 10, 2025recall325d agoAmneal Pharmaceuticals, LLC recall (Cls II)Amneal Pharmaceuticals, Inc.

    chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1056-1. — Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. — Status: Ongoing

    full page →fda recalls ↗
    ›Sep 10, 2025recall325d agoDermaRite Industries, LLC recall (Cls I)

    DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 800 ml (27 fl. oz.) bag-n-box (NDC 61924-092-27) and b) 1000ml (34 fl. oz.) bag-n-box (NDC 61924-092-34) , DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. — Reason: Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia. — Status: Ongoing

    full page →fda recalls ↗
    ›Sep 10, 2025recall325d agoAmneal Pharmaceuticals, LLC recall (Cls II)Amneal Pharmaceuticals, Inc.

    Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC 65162-272-50; Manufactured by: Amneal Pharmaceuticals, Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. — Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. — Status: Ongoing

    full page →fda recalls ↗
    ›Sep 10, 2025recall325d agoDermaRite Industries, LLC recall (Cls I)

    KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34 — Reason: Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia. — Status: Ongoing

    full page →fda recalls ↗
    ›Sep 10, 2025recall325d agoAmneal Pharmaceuticals, LLC recall (Cls II)Amneal Pharmaceuticals, Inc.

    chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1058-1. — Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. — Status: Ongoing

    full page →fda recalls ↗
    ›Sep 10, 2025recall325d agoBoothwyn Pharmacy LLC recall (Cls II)Novo Nordisk AS

    Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy — Reason: Subpotent Drug — Status: Ongoing

    full page →fda recalls ↗
    ›Sep 10, 2025recall325d agoB BRAUN MEDICAL INC recall (Cls I)B. Braun Medical Inc

    Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07 — Reason: Presence of Particulate Matter — Status: Ongoing

    full page →fda recalls ↗
    ›Sep 10, 2025recall325d agoIMMUNOCORE, LLC recall (Cls II)Immunocore Holdings plc

    KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does vial. Mfd by: Immunocore Limited, 92 Park Drive, Abingdon, Oxfordshire, OX14 4RY, United Kingdom, For: Immunocore Commercial LLC, 181 Washington St, Conshohocken, PA, 19428, Product of Denmark NDC 80446-0401-01 Lot #: 3D009AA09, 3D009AA10, 3D009AA25, Exp Date: 31 MAR 2026 NDC 80446-0401-99 (Non-Commercial FG) Lot #: 3D009AA02, Exp Date 31 MAR 2026 — Reason: Subpotent Drug — Status: Ongoing

    full page →fda recalls ↗
    ›Sep 10, 2025recall325d agoBoothwyn Pharmacy LLC recall (Cls II)Novo Nordisk AS

    Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy — Reason: Subpotent Drug — Status: Ongoing

    full page →fda recalls ↗
    ›Sep 10, 2025grant325d agoARTERY THERAPEUTICS, INC. — Manufacturing of ABCA1 agonist small molecule peptide CS6253 to support chron...Artery Therapeutics Inc

    AG grant. $2,454,521. PI: Jan Johansson

    full page →nih reporter ↗
    ›Sep 10, 2025grant325d agoUNIVERSITY OF MICHIGAN AT ANN ARBOR — Understanding and Harnessing Microbial Reprogramming to Combat Carcinogenic C...

    CA grant. $2,864,671. PI: Jiahe Li

    full page →nih reporter ↗
    ›Sep 10, 2025grant325d agoCHILDREN'S HOSP OF PHILADELPHIA — Neural markers of late language emergence in preschool children born very and...

    HD grant. $2,375,939. PI: Yu-Han Chen

    full page →nih reporter ↗
    ›Sep 10, 2025grant325d agoYALE UNIVERSITY — Aging Well with HIV through Alcohol Research and Risk Reduction and Education...

    AA grant. $1,493,442. PI: Amy Caroline Justice

    full page →nih reporter ↗
    ›Sep 10, 2025grant325d agoUNIVERSITY OF SOUTH CAROLINA AT COLUMBIA — FXTAS in Women with the FMR1 Premutation: Establishing the Profile, Predictor...

    HD grant. $548,012. PI: Jessica Klusek

    full page →nih reporter ↗
    ›Sep 10, 2025grant325d agoLAZARUS 3D, INC. — Development and Validation of a High-Fidelity Cardiac Presurgical Planning Pl...

    HL grant. $400,016. PI: Tyler Kelly

    full page →nih reporter ↗
    ›Sep 10, 2025grant325d agoCHILDREN'S HOSP OF PHILADELPHIA — Ownership of medical practices, use of intensive care service, and neonatal o...

    HD grant. $749,272. PI: Scott A Lorch

    full page →nih reporter ↗
    ›Sep 10, 2025grant325d agoUNIV OF NORTH CAROLINA CHAPEL HILL — Adventures in the Design and Trial of an Innovative FASD Risk Assessment: Int...

    AA grant. $287,684. PI: Carol L Cheatham

    full page →nih reporter ↗
    ›Sep 10, 2025grant325d agoUNIVERSITY OF ALABAMA AT BIRMINGHAM — Evaluating Healthy Families PrEP: an intervention to promote PrEP use during ...

    MH grant. $224,926. PI: Esther Cathyln Atukunda

    full page →nih reporter ↗
    ›Sep 10, 2025grant325d agoNEW YORK UNIVERSITY SCHOOL OF MEDICINE — A translational approach for novel precision medicine modelsNew York University

    AA grant. $3,168,729. PI: Charles R Marmar

    full page →nih reporter ↗
    ›Sep 10, 2025grant325d agoUT SOUTHWESTERN MEDICAL CENTER — Development of a nuclear alpha-ketoglutarate biosensor system to study metabo...

    GM grant. $1,792,800. PI: Samuel Kent McBrayer

    full page →nih reporter ↗
    ›Sep 10, 2025grant325d agoUNIVERSITY OF SOUTHERN CALIFORNIA — Transitional Alveolar Epithelial Cells in Normal Lung DevelopmentUniversity of Southern California

    HL grant. $637,913. PI: Parviz Minoo Minoo

    full page →nih reporter ↗
    ›Sep 10, 2025grant325d agoBROWN UNIVERSITY — Associations of Prenatal PFAS Mixtures With Adult Metabolic, Vascular, and Bo...

    ES grant. $463,850. PI: Joseph M Braun

    full page →nih reporter ↗
    ›Sep 10, 2025grant325d agoUNIVERSITY OF TX MD ANDERSON CAN CTR — Evaluating Antigen Spread After cDC1 Vaccination

    CA grant. $37,598. PI: Morgan Nicole Riba

    full page →nih reporter ↗
    ›Sep 10, 2025grant325d agoNORTHWESTERN UNIVERSITY AT CHICAGO — Selenium Supplementation for Moderate-Severe Ulcerative Colitis FlaresNorthwestern University

    DK grant. $320,000. PI: Parambir Singh Dulai

    full page →nih reporter ↗
    ›Sep 10, 2025grant325d agoUNIVERSITY OF TEXAS HLTH SCIENCE CENTER — Glucagon-mediated glycemic effect in humans with and without rerouted gut aft...Xeris Biopharma Holdings, Inc.

    DK grant. $775,865. PI: Marzieh Salehi

    full page →nih reporter ↗
    ›Sep 10, 2025grant325d agoWAKE FOREST UNIVERSITY HEALTH SCIENCES — Cellular Stress in Pain and Tissue DamageWake Forest University

    AR grant. $1,950,412. PI: E. Alfonso Romero-Sandoval

    full page →nih reporter ↗
    ›Sep 10, 2025grant325d agoUNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN — Investigating Transplacental Immune Pathways Contributing to Fetal Brain Path...PATH

    HD grant. $535,039. PI: Adrienne M Antonson

    full page →nih reporter ↗
    ›Sep 10, 2025grant325d agoUT SOUTHWESTERN MEDICAL CENTER — Immune Checkpoint-Engineered oligodendrocytes as treatment for multiple scler...

    AI grant. $300,000. PI: OLAF STUVE

    full page →nih reporter ↗
    ›Sep 10, 2025grant325d agoJOHNS HOPKINS UNIVERSITY — Wearable Insoles for Recurrent Diabetic Ulcer Prevention (WIREDUP)Johns Hopkins University

    DK grant. $806,274. PI: Caitlin Whitney Hicks

    full page →nih reporter ↗
    ›Sep 10, 2025grant325d agoICAHN SCHOOL OF MEDICINE AT MOUNT SINAI — Endocrine-Disrupting Chemical (EDC) Mixtures in Relation to Metabolic Syndrom...

    ES grant. $126,970. PI: Sandra India Aldana

    full page →nih reporter ↗
    ›Sep 10, 2025grant325d agoUNIVERSITY OF OREGON — Mechanism and therapeutic potential of BefA, a bacterial protein that promote...

    DK grant. $1,287,252. PI: Karen J Guillemin

    full page →nih reporter ↗
    ›Sep 10, 2025grant325d agoUNIVERSITY OF SOUTHERN CALIFORNIA — Alcohol metabolism and disease risk in Asians: Examining the impact of person...University of Southern California

    AA grant. $746,544. PI: Susan E. Luczak

    full page →nih reporter ↗
    ›Sep 10, 2025grant325d agoUNIVERSITY OF WISCONSIN-MADISON — The Development of the Approximate Number System in Humans and Monkeys

    HD grant. $514,457. PI: Stephen Ferrigno

    full page →nih reporter ↗
    ›Sep 10, 2025grant325d agoHEBREW REHABILITATION CENTER FOR AGED — Strengthening Recovery - Integrating Intrinsic Capacity Care into Post-Acute ...

    AG grant. $243,000. PI: Sandra Shi

    full page →nih reporter ↗
    ›Sep 10, 2025grant325d agoMASSACHUSETTS GENERAL HOSPITAL — Illuminating Proximal Relational Dynamics to Enhance Initial Recovery from Al...Massachusetts General Hospital

    AA grant. $197,626. PI: Samuel Fisher Acuff

    full page →nih reporter ↗
    ›Sep 10, 2025grant325d agoSOCIALRX INC — Member Engagement Application for Personalized Arts-Based Social Prescriptions

    AT grant. $293,920. PI: Dawn McDaniel

    full page →nih reporter ↗
    ›Sep 10, 2025grant325d agoNORTHSTAR GENOMICS, LLC — Novel approaches to humanized skeletal muscle in pig

    AR grant. $286,415. PI: MARY G GARRY

    full page →nih reporter ↗
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