Calendar

Week of Jan 26, 2026

Jan 26, 2026device recall201d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X — Reason: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. — Status: Ongoing

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Jan 26, 2026grant201d agoFLORIDA INTERNATIONAL UNIVERSITY — CRISPR/dCas9-Targeted Histone Demethylation Interplays with DNA Repair to Con...

NS grant. $1,319,674. PI: Prem P Chapagain

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Jan 26, 2026grant201d agoEMORY UNIVERSITY — Neuromodulation of somato-sympathetic postganglionic activity after SCIEmory University

NS grant. $234,750. PI: SHAWN HOCHMAN

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Jan 27, 2026approval200d agoDARZALEX FASPRO (DARATUMUMAB AND HYALURONIDASE-FIHJ) — FDA approval(daratumumab + hyaluronidase (human recombinant))

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

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Jan 27, 2026approval200d agoNOXAFIL POWDERMIX KIT (POSACONAZOLE) — FDA approvalPOSACONAZOLE

Sponsor: MSD MERCK CO. Form: FOR SUSPENSION, DELAYED RELEASE. Route: ORAL

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Jan 27, 2026approval200d agoTAPENTADOL HYDROCHLORIDE — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: HUMANWELL. Form: TABLET. Route: ORAL

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Jan 27, 2026approval200d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

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Jan 27, 2026approval200d agoFIDAXOMICIN — FDA approvalDificid

Sponsor: TORRENT. Form: TABLET. Route: ORAL

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Jan 27, 2026approval200d agoVYXEOS (CYTARABINE) — FDA approvalMeitheal Pharmaceuticals Inc

Sponsor: JAZZ PHARMS THERAP. Form: POWDER. Route: INTRAVENOUS

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Jan 27, 2026approval200d agoMESNA — FDA approvalRiconpharma LLC

Sponsor: EUGIA PHARMA. Form: INJECTABLE. Route: INTRAVENOUS

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Jan 27, 2026approval200d agoTOPIRAMATE — FDA approvaltopiramate ER

Sponsor: NATCO. Form: TABLET. Route: ORAL

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Jan 27, 2026approval200d agoPROPRANOLOL HYDROCHLORIDE — FDA approvalpropranolol hydrochloride ER

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

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Jan 27, 2026approval200d agoIDOSE TR (TRAVOPROST) — FDA approvalTRAVOPROST

Sponsor: GLAUKOS. Form: IMPLANT. Route: INTRACAMERAL

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Jan 27, 2026approval200d agoIDOSE TR (TRAVOPROST) — FDA approvalTRAVOPROST

Sponsor: GLAUKOS. Form: IMPLANT. Route: INTRACAMERAL

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Jan 27, 2026approval200d agoNOXAFIL (POSACONAZOLE) — FDA approvali3 Pharmaceuticals LLC

Sponsor: SCHERING. Form: SUSPENSION. Route: ORAL

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Jan 27, 2026approval200d agoCAPECITABINE — FDA approvalArmas Pharmaceuticals Inc

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

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Jan 27, 2026approval200d agoCAPRELSA (VANDETANIB) — FDA approvalvandetanib

Sponsor: GENZYME CORP. Form: TABLET. Route: ORAL

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Jan 27, 2026approval200d agoPRIFTIN (RIFAPENTINE) — FDA approvalrifapentine

Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL

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Jan 27, 2026approval200d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

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Jan 27, 2026approval200d agoDEFLAZACORT — FDA approvalAmneal Pharmaceuticals, Inc.

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

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Jan 27, 2026approval200d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

Sponsor: MERCK SHARP DOHME. Form: TABLET, DELAYED RELEASE. Route: ORAL

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Jan 27, 2026device 510k200d agoSoniquence, LLC — Reusable 3 Button Fingerswitch Wand (510k cleared)

Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Special

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Jan 27, 2026device 510k200d agoBalt USA, LLC — Optima Coil System (OptiOne Coil System) (510k cleared)Bayer USA LLC

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

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Jan 27, 2026device 510k200d agoInbella Medical, Inc. — InbellaIgnite RF System (510k cleared)

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

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Jan 27, 2026device 510k200d agoBeckman Coulter, Inc. — Access anti-HAV IgM (510k cleared)

Product code: LOL. Advisory committee: Microbiology. Type: Traditional

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Jan 27, 2026device 510k200d agoAidoc Medical , Ltd. — BriefCase-Triage (510k cleared)

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

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Jan 27, 2026device pma200d agoBoston Scientific Corp — WOLVERINE Coronary Cutting Balloon (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Jan 27, 2026device pma200d agoMedtronic Vascular — Endurant Stent Graft System; Endurant II/IIs Stent Graft System; Endurant II AUI Stent Graft System (PMA supplement)

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

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Jan 27, 2026device recall200d agoAbiomed, Inc. device recall (Cls I)Abion Inc

Impella RP Flex with SmartAssist. Product Code: 1000323. — Reason: Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. — Status: Ongoing

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Jan 27, 2026device recall200d agoAbiomed, Inc. device recall (Cls I)Abion Inc

Impella RP with SmartAssist. Product Code: 0046-0035. — Reason: Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. — Status: Ongoing

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Jan 27, 2026device recall200d agoAbiomed, Inc. device recall (Cls I)Abion Inc

Impella RP. Product Code: 0046-0011. — Reason: Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. — Status: Ongoing

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Jan 27, 2026device recall200d agoBecton Dickinson & Company device recall (Cls II)BECTON DICKINSON & CO

10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case. — Reason: During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes. — Status: Ongoing

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Jan 27, 2026device recall200d agoLutronic Corporation device recall (Cls II)

CLARITY II Laser System; Model No. 1110200210. — Reason: Reports of devices sparking/popping and potentially burning patients. — Status: Ongoing

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Jan 27, 2026grant200d agoUNIVERSITY OF MINNESOTA — Testing the role of microbial infections in the development of auto-antibodie...University of Minnesota

AI grant. $43,914. PI: Adrianna M. Rivera-León

full page →nih reporter ↗

Jan 27, 2026grant200d agoUNIVERSITY OF CALIFORNIA LOS ANGELES — Predicting ASD Outcomes Using Quantitative Movement Metrics in InfancyUniversity of California Los Angeles

NS grant. $625,859. PI: Rujuta Bhatt Wilson

full page →nih reporter ↗

Jan 27, 2026grant200d agoALBERT EINSTEIN COLLEGE OF MEDICINE — Understanding how T cell receptor recognition of peptide ligands shapes memor...Albert Einstein College of Medicine

AI grant. $780,787. PI: Gregoire Stephane Lauvau

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Jan 28, 2026approval199d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL

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Jan 28, 2026approval199d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: POWDER. Route: INTRAVENOUS

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Jan 28, 2026approval199d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: FOR SUSPENSION. Route: ORAL

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Jan 28, 2026approval199d agoALENDRONATE SODIUM — FDA approvalALENDRONATE SODIUM

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

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Jan 28, 2026approval199d agoALENDRONATE SODIUM — FDA approvalALENDRONATE SODIUM

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →ALENDRONATE SODIUM →fda approvals ↗

Jan 28, 2026approval199d agoYUVEZZI (BRIMONIDINE TARTRATE) — FDA approvalBausch & Lomb Corp

Sponsor: VISUS. Form: SOLUTION/DROPS. Route: OPHTHALMIC

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Jan 28, 2026approval199d agoDAYSEE (ETHINYL ESTRADIOL) — FDA approvalNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Sponsor: LUPIN LTD. Form: TABLET. Route: ORAL

full page →NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE →fda approvals ↗

Jan 28, 2026approval199d agoISOSULFAN BLUE — FDA approvalISOSULFAN BLUE

Sponsor: MYLAN INSTITUTIONAL. Form: SOLUTION. Route: SUBCUTANEOUS

full page →ISOSULFAN BLUE →fda approvals ↗

Jan 28, 2026approval199d agoCLOMIPRAMINE HYDROCHLORIDE — FDA approvalTruPharma LLC

Sponsor: TARO. Form: CAPSULE. Route: ORAL

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Jan 28, 2026approval199d agoABILIFY MAINTENA KIT (ARIPIPRAZOLE) — FDA approvalaripiprazole LA

Sponsor: OTSUKA PHARM CO LTD. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →aripiprazole LA →fda approvals ↗

Jan 28, 2026approval199d agoSERTRALINE HYDROCHLORIDE — FDA approvalSERTRALINE HYDROCHLORIDE

Sponsor: AMNEAL. Form: CAPSULE. Route: ORAL

full page →SERTRALINE HYDROCHLORIDE →fda approvals ↗

Jan 28, 2026approval199d agoDIVALPROEX SODIUM — FDA approvalUnichem Pharmaceuticals (USA) Inc

Sponsor: UNICHEM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

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Jan 28, 2026approval199d agoDIVALPROEX SODIUM — FDA approvalUnichem Pharmaceuticals (USA) Inc

Sponsor: UNICHEM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

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Jan 28, 2026recall199d agoCipla USA, Inc. recall (Cls III)Cipla USA Inc

Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39 — Reason: Failed PH Specifications — Status: Ongoing

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Week of Jan 26, 2026