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Week of Mar 23, 2026

50

Mar 27, 2026approval143d agoZEJULA (NIRAPARIB TOSYLATE) — FDA approvalniraparib

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →niraparib →fda approvals ↗

Mar 27, 2026approval143d agoDAYBUE (TROFINETIDE) — FDA approvaltrofinetide

Sponsor: ACADIA PHARMS INC. Form: SOLUTION. Route: ORAL

full page →trofinetide →fda approvals ↗

Mar 27, 2026approval143d agoCARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER (NICARDIPINE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: CHIESI. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

Mar 27, 2026approval143d agoDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (ATROPINE SULFATE) — FDA approvalATROPINE SULFATE

Sponsor: SPECGX LLC. Form: TABLET. Route: ORAL

full page →ATROPINE SULFATE →fda approvals ↗

Mar 27, 2026approval143d agoASENAPINE MALEATE — FDA approvalASENAPINE MALEATE

Sponsor: SIGMAPHARM LABS LLC. Form: TABLET. Route: SUBLINGUAL

full page →ASENAPINE MALEATE →fda approvals ↗

Mar 27, 2026approval143d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL

full page →TRIKAFTA (COPACKAGED) →fda approvals ↗

Mar 27, 2026approval143d agoHALOPERIDOL DECANOATE — FDA approvalHALOPERIDOL DECANOATE

Sponsor: MANKIND PHARMA. Form: INJECTABLE. Route: INJECTION

full page →HALOPERIDOL DECANOATE →fda approvals ↗

Mar 27, 2026approval143d agoSPINRAZA (NUSINERSEN SODIUM) — FDA approvalBIOGEN INC.

Sponsor: BIOGEN IDEC. Form: SOLUTION. Route: INTRATHECAL

full page →fda approvals ↗

Mar 27, 2026approval143d agoLICART (DICLOFENAC EPOLAMINE) — FDA approvalAmzell Limited

Sponsor: IBSA INST BIO. Form: SYSTEM. Route: TOPICAL

full page →fda approvals ↗

Mar 27, 2026approval143d agoTRIKAFTA (COPACKAGED) (ELEXACAFTOR, IVACAFTOR, TEZACAFTOR) — FDA approvalTRIKAFTA (COPACKAGED)

Sponsor: VERTEX PHARMS INC. Form: GRANULES. Route: ORAL

full page →TRIKAFTA (COPACKAGED) →fda approvals ↗

Mar 27, 2026approval143d agoESCITALOPRAM OXALATE — FDA approvalAbbVie Inc.

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 27, 2026approval143d agoESCITALOPRAM OXALATE — FDA approvalAbbVie Inc.

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

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Mar 27, 2026approval143d agoESCITALOPRAM OXALATE — FDA approvalAbbVie Inc.

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 27, 2026approval143d agoESCITALOPRAM OXALATE — FDA approvalAbbVie Inc.

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 27, 2026approval143d agoESCITALOPRAM OXALATE — FDA approvalAbbVie Inc.

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 27, 2026approval143d agoESCITALOPRAM OXALATE — FDA approvalAbbVie Inc.

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 27, 2026approval143d agoESCITALOPRAM OXALATE — FDA approvalAbbVie Inc.

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 27, 2026approval143d agoESCITALOPRAM OXALATE — FDA approvalAbbVie Inc.

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 27, 2026approval143d agoESCITALOPRAM OXALATE — FDA approvalAbbVie Inc.

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 27, 2026approval143d agoKETAMINE HYDROCHLORIDE — FDA approvalKetalar

Sponsor: GLAND. Form: INJECTABLE. Route: INJECTION

full page →Ketalar →fda approvals ↗

Mar 27, 2026approval143d agoCLADRIBINE — FDA approvalMerck KGaA

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

full page →fda approvals ↗

Mar 27, 2026device 510k143d agoCanon Medical Systems Corporation — Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoButterfly Network, Inc. — Butterfly Gestational Age Tool (510k cleared)Butterfly Network, Inc.

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoSS GLOBAL — CyClean Cord (510k cleared)

Product code: MVL. Advisory committee: Unknown. Type: Traditional

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoETHICON, Inc. — STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoSamsung Medison Co., Ltd. — EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoPhilips Ultrasound, LLC — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoVy Spine, LLC — VyPlate Anterior Cervical Plate System (510k cleared)

Product code: KWQ. Advisory committee: Orthopedic. Type: Special

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoFoshan Dahao Medical Technology Co., Ltd. — Electric wheelchair (510k cleared)NewBay Medical Technology Co Ltd

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoMedcad — MedCAD® AccuStride System (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoStreck, LLC — MDx-Chex for BCP (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoPhilips Medical Systems Technologies , Ltd. — Spectral CT Verida Family (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoAmerican Medical Endoscopy, Inc. — Strauss Surgical cystoscope, hysteroscope and accessories Instruments (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoEsaote, S.p.A. — S-scan Open (100001800) (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoAneuvo — ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013) (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoIcu Medical, Inc. — OTTO Disinfecting Cap (510k cleared)ICU MEDICAL INC/DE

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoBoston Scientific Corporation — Asurys Fluid Management System (510k cleared)BOSTON SCIENTIFIC CORP

Product code: HIG. Advisory committee: Obstetrics/Gynecology. Type: Traditional

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoSurgical Fusion Technologies GmbH — SF Push-in Anchor (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoTerumo Corporation — Ryurei (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC — Automated Aortic Stenosis Software (AutoAS) (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoArtiness S.R.L — ARTICOR planner (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoSynergy Spine Solutions, Inc. — Synergy Disc Instruments (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoMim Software, Inc. — Contour ProtégéAI+ (510k cleared)ASURE SOFTWARE INC

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoNingbo Zhishan Medical Technology Co., Ltd. — Power wheelchair (ZS-EW8026) (510k cleared)NewBay Medical Technology Co Ltd

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoYurob Rehabilitation Medical Co., Ltd. — Electrically Powered Wheelchair (Model YC-01) (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoMedos International SARL — SYMPHONY Navigation Ready Instruments (510k cleared)

Product code: OLO. Advisory committee: Neurology. Type: Traditional

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoAventix Medical, Inc. — AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) (510k cleared)AVITA Medical, Inc.

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

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoZhuhai Fitlens Medical Technology Co., Ltd. — GPA (hexafocon A) Rigid Gas Permeable Contact Lenses (510k cleared)

Product code: HQD. Advisory committee: Ophthalmic. Type: Traditional

full page →fda device 510k ↗

Mar 27, 2026device 510k143d agoLincotek Medical — SportLinc Syndesmosis Device (510k cleared)

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

full page →fda device 510k ↗

Mar 27, 2026device pma143d agoEBR Systems, Inc. — WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System (PMA supplement)EBR Systems, Inc.

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

full page →fda device pma ↗

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