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Week of Feb 23, 2026

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Feb 23, 2026approval174d agoBRIVARACETAM — FDA approvalUCB SA

Sponsor: REGCON HOLDINGS. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Feb 23, 2026approval174d agoBRIVARACETAM — FDA approvalCentaur Pharmaceuticals Pvt Ltd

Sponsor: CENTAUR PHARMS PVT. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Feb 23, 2026approval174d agoMYCOPHENOLATE MOFETIL — FDA approvalMYCOPHENOLATE MOFETIL

Sponsor: AMNEAL. Form: FOR SUSPENSION. Route: ORAL

full page →MYCOPHENOLATE MOFETIL →fda approvals ↗

Feb 23, 2026approval174d agoBRIVARACETAM — FDA approvalBRIVARACETAM

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →BRIVARACETAM →fda approvals ↗

Feb 23, 2026approval174d agoSODIUM PHOSPHATES (SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE) — FDA approval

Sponsor: CAPLIN. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

Feb 23, 2026approval174d agoBRIVARACETAM — FDA approvalBRIVARACETAM

Sponsor: MICRO LABS. Form: SOLUTION. Route: INTRAVENOUS

full page →BRIVARACETAM →fda approvals ↗

Feb 23, 2026approval174d agoBRIVARACETAM — FDA approvalBRIVARACETAM

Sponsor: MSN. Form: SOLUTION. Route: INTRAVENOUS

full page →BRIVARACETAM →fda approvals ↗

Feb 23, 2026approval174d agoIPRATROPIUM BROMIDE — FDA approvalArmstrong Pharmaceuticals Inc

Sponsor: ARMSTRONG PHARMS. Form: AEROSOL, METERED. Route: INHALATION

full page →fda approvals ↗

Feb 23, 2026approval174d agoTOPIRAMATE — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

Sponsor: SUN PHARM INDS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Feb 23, 2026approval174d agoTOPIRAMATE — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

Sponsor: SUN PHARM INDS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Feb 23, 2026approval174d agoTOPIRAMATE — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

Sponsor: SUN PHARM INDS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Feb 23, 2026approval174d agoTOPIRAMATE — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

Sponsor: SUN PHARM INDS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Feb 23, 2026approval174d agoTOPIRAMATE — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

Sponsor: SUN PHARM INDS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Feb 23, 2026approval174d agoTOPIRAMATE — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

Sponsor: SUN PHARM INDS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Feb 23, 2026approval174d agoTOPIRAMATE — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

Sponsor: SUN PHARM INDS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Feb 23, 2026approval174d agoTOPIRAMATE — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

Sponsor: SUN PHARM INDS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Feb 23, 2026approval174d agoPREGABALIN — FDA approvalViatris Inc

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

full page →fda approvals ↗

Feb 23, 2026approval174d agoBRIVARACETAM — FDA approvalUCB SA

Sponsor: ZHEJIANG POLY PHARM. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Feb 23, 2026approval174d agoDILTIAZEM HYDROCHLORIDE — FDA approvalZydus Therapeutics Inc

Sponsor: ZYDUS PHARMS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Feb 23, 2026approval174d agoDILTIAZEM HYDROCHLORIDE — FDA approvalZydus Therapeutics Inc

Sponsor: ZYDUS PHARMS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Feb 23, 2026approval174d agoBRIVARACETAM — FDA approvalUCB SA

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

full page →fda approvals ↗

Feb 23, 2026approval174d agoSUSTOL (GRANISETRON) — FDA approvalgranisetron ER

Sponsor: HERON THERAPS INC. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →granisetron ER →fda approvals ↗

Feb 23, 2026approval174d agoPREGABALIN — FDA approvalPREGABALIN

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

full page →PREGABALIN →fda approvals ↗

Feb 23, 2026approval174d agoPREGABALIN — FDA approvalPREGABALIN

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

full page →PREGABALIN →fda approvals ↗

Feb 23, 2026approval174d agoLOARGYS (PEGZILARGINASE-NBLN) — FDA approvalpegzilarginase

Sponsor: IMMEDICA PHARMA AB. Form: Injectable. Route: Injection

full page →pegzilarginase →fda approvals ↗

Feb 23, 2026device 510k174d agoPoskom Co., Ltd. — AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) (510k cleared)

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

full page →fda device 510k ↗

Feb 23, 2026device 510k174d agoVita Zahnfabrik H. Rauter GmbH & Co. Kg. — VITA VMLC Primer (510k cleared)

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

full page →fda device 510k ↗

Feb 23, 2026device 510k174d agoXenix Medical — LUX Expandable Lumbar Interbody System (510k cleared)

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

full page →fda device 510k ↗

Feb 23, 2026device 510k174d agoResmed Pty , Ltd. — Mariana Minerva; Mariana Nimbus (510k cleared)

Product code: MNS. Advisory committee: Anesthesiology. Type: Traditional

full page →fda device 510k ↗

Feb 23, 2026device 510k174d agoBox Spine, LLC — Duet Spinal Fixation System (510k cleared)

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

full page →fda device 510k ↗

Feb 23, 2026device 510k174d agoSiemens Shenzhen Magnetic Resonance , Ltd. — MAGNETOM Flow.Ace; MAGNETOM Flow.Plus (510k cleared)

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

full page →fda device 510k ↗

Feb 23, 2026device 510k174d agoArgon Medical Devices, Inc. — ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial (510k cleared)

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

full page →fda device 510k ↗

Feb 23, 2026device 510k174d agoSmart Reactors — Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) (510k cleared)

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

full page →fda device 510k ↗

Feb 23, 2026device 510k174d agoC.R. Bard, Inc. — Rubber Utility Catheter (510k cleared)

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

full page →fda device 510k ↗

Feb 23, 2026device 510k174d agoPhilips Medical Systems Nederland B.V. — Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades (510k cleared)

Product code: LNH. Advisory committee: Radiology. Type: Abbreviated

full page →fda device 510k ↗

Feb 23, 2026device 510k174d agoCMT Health PTE., Ltd. — Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe (510k cleared)Shanghai Jiao Tong University

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

full page →fda device 510k ↗

Feb 23, 2026device 510k174d agoApplied Medical Resources Corporation — Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) (510k cleared)

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

full page →fda device 510k ↗

Feb 23, 2026device 510k174d agoShenzhen Mlay Intelligent Technology Co., Ltd. — IPL Hair Removal Device (Models: T31A, T32A) (510k cleared)

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

full page →fda device 510k ↗

Feb 23, 2026device 510k174d agoJiangsu Yuyue Medical Equipment & Supply Co., Ltd. — YUWELL® Electronic Blood Pressure Monitor (YE650AR) (510k cleared)

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

full page →fda device 510k ↗

Feb 23, 2026device 510k174d agoZhejiang Wei Ling New Energy Technology Co., Ltd. — Mobility Scooter (CL-Q3, CL-Q4) (510k cleared)

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

full page →fda device 510k ↗

Feb 23, 2026device 510k174d agoSkia, Inc. — SKIA-Head (Model: SKIA-ST00) (510k cleared)

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

full page →fda device 510k ↗

Feb 23, 2026device pma174d agoABBOTT MEDICAL — Aveir DR Delivery Catheter (LSCD201) (PMA supplement)

Supplement type: Normal 180 Day Track No User Fee. Product code: PNJ. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Feb 23, 2026device pma174d agoAbbott Laboratories — ARCHITECT Total PSA / Alinity i Total PSA (LN 6C06/07P92) (PMA supplement)ABBOTT LABORATORIES

Supplement type: 30-Day Notice. Product code: MTF. Advisory committee: IM. Decision: OK30

full page →fda device pma ↗

Feb 23, 2026device pma174d agoPhysio-Control, Inc. — LIFEPAK® 35 monitor/defibrillator (PMA supplement)

Supplement type: Real-Time Process. Product code: MKJ. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Feb 23, 2026device pma174d agoMedtronic, Inc. — Miera AV TPS; Miera TPS (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Feb 23, 2026device pma174d agoInspire Medical Systems — Model 3028 Connector Block Laser Weld Inspection Update (PMA supplement)Inspire Medical Systems, Inc.

Supplement type: 30-Day Notice. Product code: MNQ. Advisory committee: AN. Decision: OK30

full page →fda device pma ↗

Feb 23, 2026device recall174d agoSiemens Healthcare Diagnostics, Inc. device recall (Cls II)

Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536; — Reason: A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use (IFU). When this issue is present, Quality Control (QC) results demonstrate a negative trend and increased imprecision. The clinical impact of a negative (A1c_E) bias may lead to a delay in diagnosis for diabetes or lead to less-than-optimal treatment for existing diabetes. — Status: Ongoing

full page →fda device recalls ↗

Feb 23, 2026device recall174d agoStryker Communications device recall (Cls II)SBA COMMUNICATIONS CORP

Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001 — Reason: Surgical light assembly may not adequate support the weight of the ceiling cover. — Status: Ongoing

full page →fda device recalls ↗

Feb 23, 2026grant174d agoUNIVERSITY OF NORTH DAKOTA — Indigenous Determinants of Prenatal Substance Use

GM grant. $84,940. PI: June-Yung Kim

full page →nih reporter ↗

Feb 23, 2026grant174d agoROCKEFELLER UNIVERSITY — Elucidating the host and viral determinants of treatment response in chronic ...

AI grant. $862,748. PI: Ype Peter De Jong

full page →nih reporter ↗

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