calendar

Dec 1, 2025grant260d agoUNIV OF NORTH CAROLINA CHAPEL HILL — Leadership and Operations Center (LOC), AIDS Clinical Trials Group

AI grant. $1. PI: Joseph J Eron

Dec 1, 2025grant260d agoUNIV OF NORTH CAROLINA CHAPEL HILL — Leadership and Operations Center (LOC), AIDS Clinical Trials Group

AI grant. $105,412. PI: Joseph J Eron

Dec 1, 2025grant260d agoASOCIACION CIVIL IMPACTA SALUD Y EDUCACN — PERU Clinical Trial Unit

AI grant. $75,000. PI: Alberto La Rosa

Dec 1, 2025grant260d agoJOHNS HOPKINS UNIVERSITY — Quantitative CEST MRI for GBM Early Response Prediction and Biopsy GuidanceJohns Hopkins University

CA grant. $350,599. PI: Shanshan Jiang

Dec 1, 2025grant260d agoDUKE UNIVERSITY — Mitigation of gastrointestinal acute radiation syndrome by promoting clusteri...Duke University

AI grant. $110,922. PI: David Guy Kirsch

Dec 1, 2025grant260d agoUNIVERSITY OF NEW HAMPSHIRE — Newt iris to lens reprogramming as a model to study eye tissue regeneration i...

GM grant. $189,459. PI: Konstantinos Sousounis

Dec 1, 2025grant260d agoVANDERBILT UNIVERSITY MEDICAL CENTER — Biomarkers of ischemic risk in adults with sickle cell disease

HL grant. $78,040. PI: Megan Aumann

Dec 1, 2025grant260d agoMEDICAL UNIVERSITY OF SOUTH CAROLINA — Orexinergic neurons, ethanol dependence, and voluntary ethanol consumption

AA grant. $75,520. PI: Christopher D Walker

Dec 1, 2025grant260d agoCLEVELAND CLINIC LERNER COM-CWRU — SMARCA5 Inhibition as a Therapeutic Target for Glioblastoma

CA grant. $41,876. PI: Molly Guthrie

Dec 1, 2025grant260d agoHARVARD MEDICAL SCHOOL — Characterizing a cortical cell-type-specific signal for navigational errors

NS grant. $44,020. PI: Henry Kyoung

Dec 1, 2025grant260d agoUTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH — Clec12A regulation of the intestinal immune response and microbiota compositionUniversity of Utah

DK grant. $42,418. PI: Morgan Harwood

Dec 1, 2025grant260d agoHARVARD UNIVERSITY — Stability of Odor Representations in the Olfactory Tubercle

DC grant. $46,145. PI: Hannah McCalmon

Dec 1, 2025grant260d agoUNIVERSITY OF VIRGINIA — XIRP2 in Stereocilia F-Actin RepairUniversity of Virginia

DC grant. $38,922. PI: Alyssa Luz-Ricca

Dec 1, 2025grant260d agoDANA-FARBER CANCER INST — Impact of preanalytical conditions on functional cancer biomarkers

CA grant. $406,351. PI: Patrick Bhola

Dec 1, 2025grant260d agoUNIV OF NORTH CAROLINA CHAPEL HILL — Leadership and Operations Center (LOC), AIDS Clinical Trials Group

AI grant. $35,137. PI: Joseph J Eron

Dec 1, 2025grant260d agoUNIVERSITY OF MIAMI SCHOOL OF MEDICINE — Dose-Dependent and Region-Specific Impacts of siRNA mediated APP Knockdown on...

AG grant. $45,294. PI: Robyn Jo McCartan

Dec 1, 2025grant260d agoUNIVERSITY OF MICHIGAN AT ANN ARBOR — Low - Field MR Fingerprinting for Myocardial Tissue Characterization in Patie...

EB grant. $74,632. PI: Calder Sheagren

Dec 1, 2025grant260d agoUNIV OF NORTH CAROLINA CHAPEL HILL — Leadership and Operations Center (LOC), AIDS Clinical Trials Group

AI grant. $193,508. PI: Joseph J Eron

Dec 1, 2025grant260d agoUNIVERSITY OF WISCONSIN-MADISON — Light adaptation in regionally and functionally distinct retinal circuits

EY grant. $83,224. PI: Andrew Howard Miller

Dec 1, 2025grant260d agoUNIVERSITY OF CALIFORNIA, SAN FRANCISCO — MERIT Extension of Optimization of a remote intervention to improve nutrition...University of California San Francisco

CA grant. $691,400. PI: Erin Lynn Van Blarigan

Dec 1, 2025grant260d agoUNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR — Gene Regulatory Mechanisms of the Coronary Artery Disease Gene PRDM16 on Smoo...

HL grant. $145,044. PI: Brian T. Palmisano

full page →acetaminophen ER →fda approvals ↗

Dec 2, 2025approval259d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

Dec 2, 2025approval259d agoTEVIMBRA (TISLELIZUMAB-JSGR) — FDA approvalBeOne Medicines Ltd.

Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION

Dec 2, 2025approval259d agoOLANZAPINE — FDA approvalTorrent Pharma Inc

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

Dec 2, 2025approval259d agoJAYPIRCA (PIRTOBRUTINIB) — FDA approvalEli Lilly and Co

Sponsor: LOXO ONCOL. Form: TABLET. Route: ORAL

Dec 2, 2025approval259d agoPROPOFOL — FDA approvalBika Biotechnology Guanzhou Co Ltd

Sponsor: NANJING KING FRIEND. Form: INJECTABLE. Route: INJECTION

full page →LEVETIRACETAM →fda approvals ↗

Dec 2, 2025approval259d agoLEVETIRACETAM — FDA approvalLEVETIRACETAM

Sponsor: KNACK. Form: INJECTABLE. Route: INTRAVENOUS

Dec 2, 2025approval259d agoSITAGLIPTIN AND METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) — FDA approvalmetformin hydrochloride ER

Sponsor: SANDOZ. Form: TABLET. Route: ORAL

full page →metformin hydrochloride ER →fda approvals ↗

Dec 2, 2025device 510k259d agoBecton, Dickinson and Company — 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe (510k cleared)BECTON DICKINSON & CO

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

Dec 2, 2025device 510k259d agoIntuitive Surgical, Inc. — da Vinci SP Surgical System (SP1098) (510k cleared)INTUITIVE SURGICAL INC

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

Dec 2, 2025device 510k259d agoChangzhou New Med Micro-Medtech Co., Ltd. — Disposable Endoscopic Injection Needles (510k cleared)

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

Dec 2, 2025device 510k259d agoAura Wellness, LLC — Aura Wave (510k cleared)

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

Dec 2, 2025device 510k259d agoMighty Oak Medical — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (510k cleared)

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

full page →fda device pma ↗

Dec 2, 2025device pma259d agoMedtronic, Inc. — Micra A V2 TPS (MC2AVR1); Micra VR2 TPS (MC2VR01) (PMA supplement)Medtronic plc

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

Dec 2, 2025device recall259d agoZimmer, Inc. device recall (Cls II)

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Right, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing

Dec 2, 2025device recall259d agoZimmer, Inc. device recall (Cls II)

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Right, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing

Dec 2, 2025device recall259d agoZimmer, Inc. device recall (Cls II)

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Left, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing

Dec 2, 2025device recall259d agoMicrobiologics Inc device recall (Cls II)FibroBiologics, Inc.

KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P — Reason: Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. — Status: Ongoing

Dec 2, 2025device recall259d agoZimmer, Inc. device recall (Cls II)

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Right, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing

Dec 2, 2025device recall259d agoZimmer, Inc. device recall (Cls II)

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815809280 Software Version: N/A Product Description: Affixus 9 mm, Length 280 mm, Left, Priformis Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing

Dec 2, 2025device recall259d agoZimmer, Inc. device recall (Cls II)

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Left, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing

Dec 2, 2025device recall259d agoZimmer, Inc. device recall (Cls II)

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Right, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing

Dec 2, 2025device recall259d agoZimmer, Inc. device recall (Cls II)

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Right, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing

Dec 2, 2025device recall259d agoZimmer, Inc. device recall (Cls II)

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Left, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing

Dec 2, 2025device recall259d agoMicrobiologics Inc device recall (Cls II)FibroBiologics, Inc.

KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K — Reason: Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. — Status: Ongoing

Dec 2, 2025device recall259d agoMicrobiologics Inc device recall (Cls II)FibroBiologics, Inc.

LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L — Reason: Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. — Status: Ongoing

Dec 2, 2025device recall259d agoZimmer, Inc. device recall (Cls II)

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Left, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing

Dec 2, 2025device recall259d agoZimmer, Inc. device recall (Cls II)

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Right, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing

Dec 2, 2025device recall259d agoZimmer, Inc. device recall (Cls II)

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Left, Trochanteric Nail Component: N/A — Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. — Status: Ongoing