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Intalight Secures CE Mark for DREAM OCT Platform, Clears Path for Commercialization in Europe

Intalight has announced that it has received CE Mark approval for its next-generation DREAM OCT plat...

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Intalight Secures CE Mark for DREAM OCT Platform, Clears Path for Commercialization in Europe
May 16, 2025
Over 70,000 Eye Products Recalled in USA After FDA Audit

A voluntary nationwide recall of multiple ophthalmic products was issued on May 12, citing potential...

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Over 70,000 Eye Products Recalled in USA After FDA Audit
May 13, 2025
FDA Grants Clearance for OcuMet Beacon Retinal Imaging Device

OcuSciences, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted regulat...

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FDA Grants Clearance for OcuMet Beacon Retinal Imaging Device
May 06, 2025
EMA CHMP Issues Positive Opinion for Teprotumumab (Tepezza) in Thyroid Eye Disease

EMA has announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positi...

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EMA CHMP Issues Positive Opinion for Teprotumumab (Tepezza) in Thyroid Eye Disease
May 06, 2025
FDA Grants RMAT Designation to 4D Molecular Therapeutics' 4D-150 for Diabetic Macular Edema

4D Molecular Therapeutics (4DMT) has announced that the U.S. Food and Drug Administration (FDA) has ...

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FDA Grants RMAT Designation to 4D Molecular Therapeutics' 4D-150 for Diabetic Macular Edema
May 05, 2025
FDA Grants Fast Track Designation to OKYO Pharma’s Urcosimod for Neuropathic Corneal Pain

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to OKYO Pharma for it...

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FDA Grants Fast Track Designation to OKYO Pharma’s Urcosimod for Neuropathic Corneal Pain
May 05, 2025
FDA Expands Luminopia’s Label to Include Amblyopia Patients Aged 8 to 12

Luminopia has announced that the U.S. Food and Drug Administration (FDA) has expanded the label of i...

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FDA Expands Luminopia’s Label to Include Amblyopia Patients Aged 8 to 12
April 30, 2025
FDA Issues Complete Response Letter to Regeneron for EYLEA HD sBLA on Extended Dosing Intervals

Regeneron Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has issued ...

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FDA Issues Complete Response Letter to Regeneron for EYLEA HD sBLA on Extended Dosing Intervals
April 22, 2025
BVI Medical Receives FDA 510(k) Clearance for Leos Glaucoma Surgical System

BVI Medical has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its i...

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BVI Medical Receives FDA 510(k) Clearance for Leos Glaucoma Surgical System
April 18, 2025
FDA Accepts Outlook Therapeutics’ Biologics License Application for ONS-5010 in Wet AMD

The U.S. Food and Drug Administration (FDA) has accepted the resubmitted Biologics License Applicati...

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FDA Accepts Outlook Therapeutics’ Biologics License Application for ONS-5010 in Wet AMD
April 10, 2025
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