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Week of Feb 9, 2026

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Feb 11, 2026device pma184d agoAlcon Laboratories, Inc. — AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (PMA supplement)Alcon Laboratories Inc

Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30

full page →fda device pma ↗

Feb 11, 2026device pma184d agoBoston Scientific Corporation — AGENT Paclitaxel-Coated Balloon Catheter (PMA supplement)BOSTON SCIENTIFIC CORP

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

full page →fda device pma ↗

Feb 11, 2026device pma184d agoABBOTT MEDICAL — HeartMate 3 Left Ventricular Assist System (PMA supplement)

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

full page →fda device pma ↗

Feb 11, 2026device pma184d agoAgilent Technologies, Inc. — PD-L1 IHC 22C3 pharmDx (PMA supplement)AGILENT TECHNOLOGIES, INC.

Supplement type: Panel Track. Product code: PLS. Advisory committee: PA. Decision: APPR

full page →fda device pma ↗

Feb 11, 2026device recall184d agoBurlington Medical, LLC device recall (Cls II)

Burlington Medical, Wrap Aprons. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing

full page →fda device recalls ↗

Feb 11, 2026device recall184d agoBurlington Medical, LLC device recall (Cls II)

Burlington Medical, Leg Wraps. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing

full page →fda device recalls ↗

Feb 11, 2026device recall184d agoBurlington Medical, LLC device recall (Cls II)

Burlington Medical, Half Aprons. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing

full page →fda device recalls ↗

Feb 11, 2026device recall184d agoBurlington Medical, LLC device recall (Cls II)

Burlington Medical, Vest — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing

full page →fda device recalls ↗

Feb 11, 2026device recall184d agoBurlington Medical, LLC device recall (Cls II)

Burlington Medical, Demi Half Aprons. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing

full page →fda device recalls ↗

Feb 11, 2026device recall184d agoCareFusion 303, Inc. device recall (Cls II)

BD Alaris" System with Guardrails" Suite MX with Point of Care Unit — Reason: Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units — Status: Ongoing

full page →fda device recalls ↗

Feb 11, 2026device recall184d agoBurlington Medical, LLC device recall (Cls II)

Burlington Medical, Kilt Blockers. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing

full page →fda device recalls ↗

Feb 11, 2026device recall184d agoWaldemar Link GmbH & Co. KG (Mfg Site) device recall (Cls II)

Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62; — Reason: The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct. — Status: Ongoing

full page →fda device recalls ↗

Feb 11, 2026device recall184d agoBurlington Medical, LLC device recall (Cls II)

Burlington Medical, Protective Sleeves. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing

full page →fda device recalls ↗

Feb 11, 2026device recall184d agoBurlington Medical, LLC device recall (Cls II)

Burlington Medical, Frontal Aprons — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing

full page →fda device recalls ↗

Feb 11, 2026device recall184d agoBurlington Medical, LLC device recall (Cls II)

Burlington Medical, Blockers. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing

full page →fda device recalls ↗

Feb 11, 2026device recall184d agoWaldemar Link GmbH & Co. KG (Mfg Site) device recall (Cls II)

Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63; — Reason: The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct. — Status: Ongoing

full page →fda device recalls ↗

Feb 11, 2026device recall184d agoBurlington Medical, LLC device recall (Cls II)

Burlington Medical, Thyroid Shield. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing

full page →fda device recalls ↗

Feb 11, 2026device recall184d agoBurlington Medical, LLC device recall (Cls II)

Burlington Medical, Caps. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing

full page →fda device recalls ↗

Feb 11, 2026device recall184d agoBurlington Medical, LLC device recall (Cls II)

Burlington Medical, Kilt — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing

full page →fda device recalls ↗

Feb 11, 2026device recall184d agoBurlington Medical, LLC device recall (Cls II)

Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage. — Reason: Potential for attenuation degradation over time, decreasing the lifespan. — Status: Ongoing

full page →fda device recalls ↗

Feb 11, 2026grant184d agoUNIVERSITY OF TEXAS SAN ANTONIO — Development of small molecule inhibitors of RBM46 as novel male contraceptives

HD grant. $743,116. PI: Christopher Bennett Geyer

full page →nih reporter ↗

Feb 11, 2026grant184d agoCLEVELAND CLINIC LERNER COM-CWRU — Pathogenesis of Permanent Neurological Disability in Multiple Sclerosis

NS grant. $544,568. PI: BRUCE D TRAPP

full page →nih reporter ↗

Feb 11, 2026grant184d agoUNIVERSITY OF IOWA — Identifying novel regulators of Tfh cell differentiation that can be targeted...University of Iowa

AI grant. $427,625. PI: Ryan Zander

full page →nih reporter ↗

Feb 11, 2026grant184d agoUNIVERSITY OF PITTSBURGH AT PITTSBURGH — A parabrachial hub for the prioritization of pain and other survival behaviors

NS grant. $620,504. PI: John Nicholas Betley

full page →nih reporter ↗

Feb 11, 2026grant184d agoUNIVERSITY OF PENNSYLVANIA — Single-nucleus gene expression and chromatin accessibility profiling of sleep...University of Pennsylvania

NS grant. $243,750. PI: Xiaofeng Guo

full page →nih reporter ↗

Feb 11, 2026grant184d agoUNIVERSITY OF DELAWARE — Evaluating Force Deficits During Bimanual Coordination in Parkinson's Disease...Metallomix Inc

NS grant. $80,000. PI: Roxana Gabriela Burciu

full page →nih reporter ↗

Feb 11, 2026grant184d agoBAYLOR COLLEGE OF MEDICINE — STATE-DEPENDENT MODULATION OF CEREBELLAR FUNCTIONBaylor College of Medicine

NS grant. $508,533. PI: JAVIER F MEDINA

full page →nih reporter ↗

Feb 11, 2026grant184d agoUNIVERSITY OF PENNSYLVANIA — The impact of a personalized video-based stroke educational platform onpatien...University of Pennsylvania

NS grant. $644,345. PI: Christopher G. Favilla

full page →nih reporter ↗

Feb 11, 2026grant184d agoINDIANA UNIVERSITY INDIANAPOLIS — World Parkinson Congress 2026 Support

NS grant. $25,000. PI: Maria de Lourdes Gamez Tansey

full page →nih reporter ↗

Feb 12, 2026approval183d agoCLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →CLEOCIN →fda approvals ↗

Feb 12, 2026approval183d agoCLEOCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) — FDA approvalclindamycin hydrochloride

Sponsor: PFIZER. Form: CAPSULE. Route: ORAL

full page →clindamycin hydrochloride →fda approvals ↗

Feb 12, 2026approval183d agoCLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) — FDA approvalCLEOCIN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →CLEOCIN →fda approvals ↗

Feb 12, 2026approval183d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

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

full page →tramadol hydrochloride ER →fda approvals ↗

Feb 12, 2026approval183d agoENJUVIA (ESTROGENS, CONJUGATED SYNTHETIC B) — FDA approvalENJUVIA

Sponsor: ASPEN. Form: TABLET. Route: ORAL

full page →ENJUVIA →fda approvals ↗

Feb 12, 2026approval183d agoFLUOROMETHOLONE — FDA approvalDifGen Pharmaceuticals LLC

Sponsor: DIFGEN PHARMS. Form: SUSPENSION/DROPS. Route: OPHTHALMIC

full page →fda approvals ↗

Feb 12, 2026approval183d agoLEQVIO (INCLISIRAN SODIUM) — FDA approvalinclisiran

Sponsor: NOVARTIS. Form: SOLUTION. Route: SUBCUTANEOUS

full page →inclisiran →fda approvals ↗

Feb 12, 2026approval183d agoLEQVIO (INCLISIRAN SODIUM) — FDA approvalinclisiran

Sponsor: NOVARTIS. Form: SOLUTION. Route: SUBCUTANEOUS

full page →inclisiran →fda approvals ↗

Feb 12, 2026approval183d agoPROMETRIUM (PROGESTERONE) — FDA approvalIBSA Institut Biochimique SA

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

full page →fda approvals ↗

Feb 12, 2026approval183d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

Sponsor: ALKEM. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Feb 12, 2026approval183d agoADQUEY (DIFAMILAST) — FDA approvaldifamilast

Sponsor: ACROTECH BIOPHARMA. Form: OINTMENT. Route: TOPICAL

full page →difamilast →fda approvals ↗

Feb 12, 2026approval183d agoGLATOPA (GLATIRAMER ACETATE) — FDA approvalGLATIRAMER ACETATE

Sponsor: SANDOZ. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →GLATIRAMER ACETATE →fda approvals ↗

Feb 12, 2026approval183d agoENZEEVU (AFLIBERCEPT-ABZV) — FDA approvalaflibercept biosimilar

Sponsor: SANDOZ INC. Form: INJECTABLE. Route: INJECTION

full page →aflibercept biosimilar →fda approvals ↗

Feb 12, 2026approval183d agoBIJUVA (ESTRADIOL) — FDA approval(estradiol + progesterone)

Sponsor: MAYNE PHARMA. Form: CAPSULE. Route: ORAL

full page →(estradiol + progesterone) →fda approvals ↗

Feb 12, 2026approval183d agoESTRING (ESTRADIOL) — FDA approvalestradiol ER

Sponsor: PFIZER. Form: INSERT, EXTENDED RELEASE. Route: VAGINAL

full page →estradiol ER →fda approvals ↗

Feb 12, 2026approval183d agoPEPCID AC (FAMOTIDINE) — FDA approvalKenvue Inc.

Sponsor: KENVUE BRANDS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Feb 12, 2026approval183d agoAMMONIUM LACTATE — FDA approvalAMMONIUM LACTATE

Sponsor: ZYDUS LIFESCIENCES. Form: CREAM. Route: TOPICAL

full page →AMMONIUM LACTATE →fda approvals ↗

Feb 12, 2026approval183d agoGLATOPA (GLATIRAMER ACETATE) — FDA approvalGLATIRAMER ACETATE

Sponsor: SANDOZ. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →GLATIRAMER ACETATE →fda approvals ↗

Feb 12, 2026approval183d agoDIVIGEL (ESTRADIOL) — FDA approvalVertical Pharmaceuticals LLC

Sponsor: VERTICAL PHARMS. Form: GEL. Route: TRANSDERMAL

full page →fda approvals ↗

Feb 12, 2026approval183d agoCENESTIN (ESTROGENS, CONJUGATED SYNTHETIC A) — FDA approvalCENESTIN

Sponsor: ASPEN. Form: TABLET. Route: ORAL

full page →CENESTIN →fda approvals ↗

Feb 12, 2026approval183d agoDARZALEX FASPRO (DARATUMUMAB AND HYALURONIDASE-FIHJ) — FDA approval(daratumumab + hyaluronidase (human recombinant))

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

full page →(daratumumab + hyaluronidase (human recombinant)) →fda approvals ↗

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