Calendar

Week of Jan 12, 2026

Jan 12, 2026grant230d agoMEDSTAR HEALTH RESEARCH INSTITUTE — STRONG HEART STUDY (SHS) - MEDSTAR HEALTH RESEARCH INSTITUTE, INC., FIELD CEN...

HL grant. $129,024. PI: DEDRA S BUCHWALD

full page →nih reporter ↗

Jan 12, 2026grant230d agoCOLORADO STATE UNIVERSITY — Transmission dynamics and fitness of reemerging St. Louis encephalitis virus ...

AI grant. $87,244. PI: Jenny Ann Buczek

full page →nih reporter ↗

Jan 13, 2026approval229d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

Sponsor: PH HEALTH. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jan 13, 2026approval229d agoYESAFILI (AFLIBERCEPT-JBVF) — FDA approvalYESAFILI

Sponsor: BIOCON BIOLOGICS INC. Form: INJECTABLE. Route: INJECTION

full page →YESAFILI →fda approvals ↗

Jan 13, 2026approval229d agoSODIUM BICARBONATE — FDA approvalSODIUM BICARBONATE

Sponsor: AMNEAL. Form: SOLUTION. Route: INTRAVENOUS

full page →SODIUM BICARBONATE →fda approvals ↗

Jan 13, 2026approval229d agoISOVUE-250 (IOPAMIDOL) — FDA approval

Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Jan 13, 2026approval229d agoISOVUE-370 (IOPAMIDOL) — FDA approval

Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Jan 13, 2026approval229d agoBENAZEPRIL HYDROCHLORIDE — FDA approvalBENAZEPRIL HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA. Form: TABLET. Route: ORAL

full page →BENAZEPRIL HYDROCHLORIDE →fda approvals ↗

Jan 13, 2026approval229d agoDEFLAZACORT — FDA approvalDEFLAZACORT

Sponsor: ZYDUS LIFESCIENCES. Form: SUSPENSION. Route: ORAL

full page →DEFLAZACORT →fda approvals ↗

Jan 13, 2026device 510k229d agoMiach Orthopaedics, Inc. — BEAR® (Bridge-Enhanced ACL Restoration) Implant (510k cleared)

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

full page →fda device 510k ↗

Jan 13, 2026device 510k229d agoSpinal Resources, Inc. — Swedge Pedicle Screw Fixation System Bezier Rod (510k cleared)RGC RESOURCES INC

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

full page →fda device 510k ↗

Jan 13, 2026device 510k229d agoSpectrum Dynamics Medical, Ltd. — VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) (510k cleared)

Product code: KPS. Advisory committee: Radiology. Type: Special

full page →fda device 510k ↗

Jan 13, 2026device 510k229d agoDmp Dental Industry S.A. — Bright Cavity Liner (510k cleared)

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

full page →fda device 510k ↗

Jan 13, 2026device 510k229d agoStryker Endoscopy — Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control (510k cleared)

Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Special

full page →fda device 510k ↗

Jan 13, 2026device 510k229d agoKossan International Sdn Bhd — Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid (510k cleared)Teva Pharmaceuticals USA Inc

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

full page →fda device 510k ↗

Jan 13, 2026device pma229d agoMerz North America, Inc. — RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, Jawline indication (PMA supplement)Sustained Therapeutics Inc

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

full page →fda device pma ↗

Jan 13, 2026device pma229d agoBoston Scientific Corporation — Axonics Sacral Neuromodulation System (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30

full page →fda device pma ↗

Jan 13, 2026device pma229d agoBoston Scientific Corporation — Axonics Sacral Neuromodulation System (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30

full page →fda device pma ↗

Jan 13, 2026device pma229d agoElement Science, Inc. — Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati (PMA supplement)

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

full page →fda device pma ↗

Jan 13, 2026device pma229d agoABBOTT MEDICAL — Proclaim Dorsal Root Ganglion (DRG) Neurostimulator System (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: PMP. Advisory committee: NE. Decision: APPR

full page →fda device pma ↗

Jan 13, 2026device pma229d agoABBOTT MEDICAL — Eterna SCS and Proclaim SCS Systems (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: LGW. Advisory committee: NE. Decision: APPR

full page →fda device pma ↗

Jan 13, 2026device pma229d agoMerz North America, Inc. — COAPTITE (PMA supplement)

Supplement type: 30-Day Notice. Product code: LNM. Advisory committee: GU. Decision: OK30

full page →fda device pma ↗

Jan 13, 2026device pma229d agoFarapulse, Inc. — FARAPULSE Pulsed Field Ablation System (FARAPULSE) (PMA supplement)

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

full page →fda device pma ↗

Jan 13, 2026device pma229d agoMerz North America, Inc. — RADIESSE® Injectable Implant (PMA supplement)

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

full page →fda device pma ↗

Jan 13, 2026device recall229d agoMedtronic Perfusion Systems device recall (Cls II)

Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1 — Reason: During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design. — Status: Ongoing

full page →fda device recalls ↗

Jan 13, 2026device recall229d agoLaerdal Medical Corporation device recall (Cls II)

Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; 3) LCSU 4, RTCA; Catalog Number: 881152; — Reason: units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M. — Status: Ongoing

full page →fda device recalls ↗

Jan 13, 2026device recall229d agoBaxter Healthcare Corporation device recall (Cls II)Baxter Healthcare Corp

Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A — Reason: Pumps were released without full testing being performed, including occlusion alarm testing. — Status: Ongoing

full page →fda device recalls ↗

Jan 13, 2026grant229d agoBECKMAN RESEARCH INSTITUTE/CITY OF HOPE — The role of ALKBH5-mediated RNA demethylation in the maintenance of genomic s...City of Hope

DK grant. $450,479. PI: Zhijian Qian

full page →nih reporter ↗

Jan 14, 2026approval228d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

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

full page →fda approvals ↗

Jan 14, 2026approval228d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

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

full page →fda approvals ↗

Jan 14, 2026approval228d agoMEN'S ROGAINE (MINOXIDIL) — FDA approvalVeradermics, Inc

Sponsor: KENVUE BRANDS. Form: AEROSOL, FOAM. Route: TOPICAL

full page →fda approvals ↗

Jan 14, 2026approval228d agoELTROMBOPAG OLAMINE — FDA approvalELTROMBOPAG OLAMINE

Sponsor: MSN. Form: TABLET. Route: ORAL

full page →ELTROMBOPAG OLAMINE →fda approvals ↗

Jan 14, 2026approval228d agoMYCOPHENOLATE MOFETIL — FDA approvalMYCOPHENOLATE MOFETIL

Sponsor: AUROBINDO PHARMA LTD. Form: CAPSULE. Route: ORAL

full page →MYCOPHENOLATE MOFETIL →fda approvals ↗

Jan 14, 2026approval228d agoROGAINE (FOR WOMEN) (MINOXIDIL) — FDA approvalVeradermics, Inc

Sponsor: KENVUE BRANDS. Form: SOLUTION. Route: TOPICAL

full page →fda approvals ↗

Jan 14, 2026approval228d agoELTROMBOPAG OLAMINE — FDA approvalELTROMBOPAG OLAMINE

Sponsor: AMNEAL. Form: TABLET. Route: ORAL

full page →ELTROMBOPAG OLAMINE →fda approvals ↗

Jan 14, 2026approval228d agoFLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (FLUCONAZOLE) — FDA approvalDiflucan

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →Diflucan →fda approvals ↗

Jan 14, 2026approval228d agoAVTOZMA (TOCILIZUMAB-ANOH) — FDA approvalAVTOZMA

Sponsor: CELLTRION INC. Form: INJECTABLE. Route: INTRAVENOUS

full page →AVTOZMA →fda approvals ↗

Jan 14, 2026approval228d agoMYCOPHENOLATE MOFETIL — FDA approvalMYCOPHENOLATE MOFETIL

Sponsor: AUROBINDO PHARMA. Form: TABLET. Route: ORAL

full page →MYCOPHENOLATE MOFETIL →fda approvals ↗

Jan 14, 2026approval228d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

Sponsor: LAURUS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 14, 2026approval228d agoGLEEVEC (IMATINIB MESYLATE) — FDA approvalImatinib Mesylate Shilpa

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Imatinib Mesylate Shilpa →fda approvals ↗

Jan 14, 2026approval228d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

Sponsor: LAURUS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jan 14, 2026approval228d agoELTROMBOPAG OLAMINE — FDA approvalELTROMBOPAG OLAMINE

Sponsor: SOMERSET THERAPS LLC. Form: TABLET

full page →ELTROMBOPAG OLAMINE →fda approvals ↗

Jan 14, 2026approval228d agoELTROMBOPAG OLAMINE — FDA approvalZydus Therapeutics Inc

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

full page →fda approvals ↗

Jan 14, 2026approval228d agoLIRAGLUTIDE — FDA approvalNovo Nordisk Inc

Sponsor: ORBICULAR. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

Jan 14, 2026approval228d agoTOREMIFENE CITRATE — FDA approvalTOREMIFENE CITRATE

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →TOREMIFENE CITRATE →fda approvals ↗

Jan 14, 2026approval228d agoMYCOPHENOLATE SODIUM — FDA approvalmycophenolate sodium DR

Sponsor: AUROBINDO PHARMA LTD. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →mycophenolate sodium DR →fda approvals ↗

Jan 14, 2026approval228d agoROGAINE EXTRA STRENGTH (FOR MEN) (MINOXIDIL) — FDA approvalVeradermics, Inc

Sponsor: KENVUE BRANDS. Form: SOLUTION. Route: TOPICAL

full page →fda approvals ↗

Jan 14, 2026approval228d agoSITAGLIPTIN PHOSPHATE — FDA approvalSITAGLIPTIN PHOSPHATE

Sponsor: SANDOZ. Form: TABLET. Route: ORAL

full page →SITAGLIPTIN PHOSPHATE →fda approvals ↗

Jan 14, 2026approval228d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

Jan 14, 2026approval228d agoMETHOTREXATE SODIUM PRESERVATIVE FREE (METHOTREXATE SODIUM) — FDA approvalPFIZER INC

Sponsor: PHARMACHEMIE BV. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

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Week of Jan 12, 2026