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Week of Mar 2, 2026

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Mar 2, 2026device pma166d 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

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Mar 2, 2026device pma166d agoEndotronix, Inc. — Cordella Pulmonary Artery Sensor System (CorPASS) (PMA supplement)

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

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Mar 2, 2026device pma166d agoAlcon Research, Ltd. — AcrySof® IQ ReSTOR Posterior Chamber Intraocular Lenses (PMA supplement)Rubicon Research Ltd

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

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Mar 2, 2026device pma166d agoMicroTransponder, Inc. — Vivistim® System (PMA supplement)

Supplement type: 30-Day Notice. Product code: QPY. Advisory committee: PM. Decision: OK30

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Mar 2, 2026device pma166d agoAbbott Vascular, Inc. — Perclose ProGlide Suture-Mediated Closure System; Perclose ProStyle Suture-Mediated Closure and Repair System (PMA supplement)

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

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Mar 2, 2026device pma166d agoAbbott Vascular Devices — StarClose SE Vascular Closure System (PMA supplement)

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

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Mar 2, 2026device pma166d agoAlcon Laboratories, LLC — Clareon® Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) and Clareon® PanOptix Hydrophobic Acrylic IOL (PMA supplement)Alcon Laboratories Inc

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

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Mar 2, 2026device recall166d agoCivco Medical Instruments Co. Inc. device recall (Cls II)

eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152 — Reason: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. — Status: Ongoing

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Mar 2, 2026device recall166d agoPhilips Respironics, Inc. device recall (Cls I)

Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device. — Reason: Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient. — Status: Ongoing

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Mar 2, 2026device recall166d agoPhilips Respironics, Inc. device recall (Cls I)

Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device. — Reason: Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient. — Status: Ongoing

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Mar 2, 2026device recall166d agoCivco Medical Instruments Co. Inc. device recall (Cls II)

eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159 — Reason: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. — Status: Ongoing

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Mar 2, 2026device recall166d agoCivco Medical Instruments Co. Inc. device recall (Cls II)

eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151 — Reason: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. — Status: Ongoing

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Mar 2, 2026device recall166d agoCivco Medical Instruments Co. Inc. device recall (Cls II)

eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157 — Reason: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. — Status: Ongoing

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Mar 2, 2026device recall166d agoCivco Medical Instruments Co. Inc. device recall (Cls II)

eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150 — Reason: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. — Status: Ongoing

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Mar 2, 2026device recall166d agoPhilips Respironics, Inc. device recall (Cls I)

Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device. — Reason: Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient. — Status: Ongoing

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Mar 2, 2026device recall166d agoCivco Medical Instruments Co. Inc. device recall (Cls II)

eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156 — Reason: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. — Status: Ongoing

full page →fda device recalls ↗

Mar 2, 2026device recall166d agoPhilips Respironics, Inc. device recall (Cls I)

Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device. — Reason: In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. — Status: Ongoing

full page →fda device recalls ↗

Mar 2, 2026device recall166d agoPhilips Respironics, Inc. device recall (Cls I)

Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device. — Reason: In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. — Status: Ongoing

full page →fda device recalls ↗

Mar 2, 2026device recall166d agoCivco Medical Instruments Co. Inc. device recall (Cls II)

eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158 — Reason: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. — Status: Ongoing

full page →fda device recalls ↗

Mar 2, 2026device recall166d agoPhilips Respironics, Inc. device recall (Cls I)

Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device. — Reason: In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. — Status: Ongoing

full page →fda device recalls ↗

Mar 2, 2026device recall166d agoCivco Medical Instruments Co. Inc. device recall (Cls II)

eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149 — Reason: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. — Status: Ongoing

full page →fda device recalls ↗

Mar 2, 2026device recall166d agoPhilips Respironics, Inc. device recall (Cls I)

Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device. — Reason: In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. — Status: Ongoing

full page →fda device recalls ↗

Mar 2, 2026device recall166d agoPhilips Respironics, Inc. device recall (Cls I)

Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device. — Reason: Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient. — Status: Ongoing

full page →fda device recalls ↗

Mar 2, 2026grant166d agoTEXAS A&M AGRILIFE RESEARCH — NAMs-Decisions Center: New Approach Methods for Decisions on Industrial and C...

TR grant. $3,124,604. PI: Ivan Rusyn

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Mar 2, 2026grant166d agoOREGON HEALTH & SCIENCE UNIVERSITY — Optimizing cAMP and PKA sensors for cell-specific dissection of neuronal circ...

MH grant. $2,039,804. PI: Isabelle Rhyssa Joe Eduria Baconguis

full page →nih reporter ↗

Mar 2, 2026grant166d agoUNIVERSITY OF PENNSYLVANIA — Harnessing XNAs to Expand the Genetic Toolkit for RNA Silencing and RNA editingUniversity of Pennsylvania

GM grant. $406,250. PI: LIJUN ZHOU

full page →nih reporter ↗

Mar 2, 2026grant166d agoNORTHEASTERN UNIVERSITY — Integrated mass spectrometry strategies to decipher metabolite-protein cross ...

GM grant. $434,000. PI: Owen Samuel Skinner

full page →nih reporter ↗

Mar 2, 2026grant166d agoUNIVERSITY OF COLORADO DENVER — Classification of Disease Associated B Cell Receptors in Multiple SclerosisUniversity of Colorado Denver

NS grant. $427,712. PI: WENDY B MACKLIN

full page →nih reporter ↗

Mar 2, 2026grant166d agoIOWA STATE UNIVERSITY — Transcriptome- and proteome-wide effects of circular RNAs of SMA genes

NS grant. $420,750. PI: RAVINDRA N SINGH

full page →nih reporter ↗

Mar 2, 2026grant166d agoUTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH — Development and Application of Nicotinic Acetylcholine Receptor Targeted Pept...University of Utah

GM grant. $500,500. PI: J MICHAEL MCINTOSH

full page →nih reporter ↗

Mar 2, 2026grant166d agoNEW YORK UNIVERSITY — Replay-Driven Task Orthogonalization and Abstraction for Continual LearningNew York University

MH grant. $75,052. PI: Zhenglong Zhou

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Mar 3, 2026approval165d agoBOSENTAN — FDA approvalBOSENTAN

Sponsor: WATSON LABS INC. Form: TABLET. Route: ORAL

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Mar 3, 2026approval165d agoBOSENTAN — FDA approvalZydus Therapeutics Inc

Sponsor: ZYDUS PHARMS. Form: TABLET. Route: ORAL

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Mar 3, 2026approval165d agoBOSENTAN — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

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

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Mar 3, 2026approval165d agoBOSENTAN — FDA approvalZydus Therapeutics Inc

Sponsor: ZYDUS PHARMS. Form: TABLET, FOR SUSPENSION. Route: ORAL

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Mar 3, 2026approval165d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalACS Dobfar SpA

Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION

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Mar 3, 2026approval165d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalACS Dobfar SpA

Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION

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Mar 3, 2026approval165d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalACS Dobfar SpA

Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION

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Mar 3, 2026approval165d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalACS Dobfar SpA

Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION

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Mar 3, 2026approval165d agoBOSENTAN — FDA approvalBOSENTAN

Sponsor: NATCO PHARMA LTD. Form: TABLET, FOR SUSPENSION. Route: ORAL

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Mar 3, 2026approval165d agoBOSENTAN — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS CO. Form: TABLET. Route: ORAL

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Mar 3, 2026approval165d agoBOSENTAN — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

Sponsor: PH HEALTH. Form: TABLET. Route: ORAL

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Mar 3, 2026approval165d agoFLUTICASONE PROPIONATE — FDA approvalFougera Pharmaceuticals Inc

Sponsor: GLENMARK SPECLT. Form: AEROSOL, METERED. Route: INHALATION

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Mar 3, 2026approval165d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

Sponsor: ACTELION. Form: TABLET. Route: ORAL

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Mar 3, 2026approval165d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalACS Dobfar SpA

Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION

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Mar 3, 2026approval165d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalACS Dobfar SpA

Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION

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Mar 3, 2026approval165d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalACS Dobfar SpA

Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION

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Mar 3, 2026approval165d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalACS Dobfar SpA

Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION

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Mar 3, 2026approval165d agoBOSENTAN — FDA approvalBOSENTAN

Sponsor: NATCO PHARMA LTD. Form: TABLET. Route: ORAL

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Mar 3, 2026approval165d agoLETROZOLE — FDA approvalYiling Pharmaceutical Ltd

Sponsor: PHARMOBEDIENT. Form: TABLET. Route: ORAL

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