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Week of Feb 16, 2026

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Feb 22, 2026grant173d agoUNIVERSITY OF MICHIGAN AT ANN ARBOR — Identifying Global Rejuvenation Mechanisms in Tissues that Reverses Age-Relat...

AG grant. $43,588. PI: Angelo Anacleto

full page →nih reporter ↗

Week of Feb 23, 2026

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Feb 23, 2026approval172d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION

full page →dupilumab →fda approvals ↗

Feb 23, 2026approval172d agoEFINACONAZOLE — FDA approvalEFINACONAZOLE

Sponsor: ALEMBIC. Form: SOLUTION. Route: TOPICAL

full page →EFINACONAZOLE →fda approvals ↗

Feb 23, 2026approval172d agoBRIVARACETAM — FDA approvalBRIVARACETAM

Sponsor: LUPIN. Form: SOLUTION. Route: ORAL

full page →BRIVARACETAM →fda approvals ↗

Feb 23, 2026approval172d agoBRIVARACETAM — FDA approvalUCB SA

Sponsor: HAINAN POLY. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

Feb 23, 2026approval172d agoBRIVARACETAM — FDA approvalUCB SA

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

full page →fda approvals ↗

Feb 23, 2026approval172d agoBRIVARACETAM — FDA approvalCentaur Pharmaceuticals Pvt Ltd

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

full page →fda approvals ↗

Feb 23, 2026approval172d agoMYCOPHENOLATE MOFETIL — FDA approvalMYCOPHENOLATE MOFETIL

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

full page →MYCOPHENOLATE MOFETIL →fda approvals ↗

Feb 23, 2026approval172d agoBRIVARACETAM — FDA approvalBRIVARACETAM

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →BRIVARACETAM →fda approvals ↗

Feb 23, 2026approval172d agoSODIUM PHOSPHATES (SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE) — FDA approval

Sponsor: CAPLIN. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

Feb 23, 2026approval172d agoBRIVARACETAM — FDA approvalBRIVARACETAM

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

full page →BRIVARACETAM →fda approvals ↗

Feb 23, 2026approval172d agoBRIVARACETAM — FDA approvalBRIVARACETAM

Sponsor: MSN. Form: SOLUTION. Route: INTRAVENOUS

full page →BRIVARACETAM →fda approvals ↗

Feb 23, 2026approval172d agoIPRATROPIUM BROMIDE — FDA approvalArmstrong Pharmaceuticals Inc

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

full page →fda approvals ↗

Feb 23, 2026approval172d agoTOPIRAMATE — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

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

full page →fda approvals ↗

Feb 23, 2026approval172d agoTOPIRAMATE — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

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

full page →fda approvals ↗

Feb 23, 2026approval172d agoTOPIRAMATE — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

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

full page →fda approvals ↗

Feb 23, 2026approval172d agoTOPIRAMATE — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

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

full page →fda approvals ↗

Feb 23, 2026approval172d agoTOPIRAMATE — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

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

full page →fda approvals ↗

Feb 23, 2026approval172d agoTOPIRAMATE — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

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

full page →fda approvals ↗

Feb 23, 2026approval172d agoTOPIRAMATE — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

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

full page →fda approvals ↗

Feb 23, 2026approval172d agoTOPIRAMATE — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

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

full page →fda approvals ↗

Feb 23, 2026approval172d agoPREGABALIN — FDA approvalViatris Inc

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

full page →fda approvals ↗

Feb 23, 2026approval172d agoBRIVARACETAM — FDA approvalUCB SA

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

full page →fda approvals ↗

Feb 23, 2026approval172d agoDILTIAZEM HYDROCHLORIDE — FDA approvalZydus Therapeutics Inc

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

full page →fda approvals ↗

Feb 23, 2026approval172d agoDILTIAZEM HYDROCHLORIDE — FDA approvalZydus Therapeutics Inc

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

full page →fda approvals ↗

Feb 23, 2026approval172d agoBRIVARACETAM — FDA approvalUCB SA

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

full page →fda approvals ↗

Feb 23, 2026approval172d agoSUSTOL (GRANISETRON) — FDA approvalgranisetron ER

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

full page →granisetron ER →fda approvals ↗

Feb 23, 2026approval172d agoPREGABALIN — FDA approvalPREGABALIN

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

full page →PREGABALIN →fda approvals ↗

Feb 23, 2026approval172d agoPREGABALIN — FDA approvalPREGABALIN

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

full page →PREGABALIN →fda approvals ↗

Feb 23, 2026approval172d agoLOARGYS (PEGZILARGINASE-NBLN) — FDA approvalpegzilarginase

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

full page →pegzilarginase →fda approvals ↗

Feb 23, 2026device 510k172d 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 510k172d 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 510k172d 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 510k172d 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 510k172d 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 510k172d 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 510k172d 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 510k172d 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 510k172d 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 510k172d 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 510k172d 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 510k172d 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 510k172d 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 510k172d 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 510k172d 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 510k172d 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 pma172d 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 pma172d 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 pma172d 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 pma172d 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 ↗

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