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FDA Approves Amneal Pharmaceuticals’ Cyclosporine Ophthalmic Emulsion 0.05%

The U.S. Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals’ cyclosporine ophtha...

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FDA Approves Amneal Pharmaceuticals’ Cyclosporine Ophthalmic Emulsion 0.05%
December 04, 2025
Celltrion Receives Health Canada Approval for Eydenzelt

Celltrion, Inc. has announced that Health Canada has approved Eydenzelt, a biosimilar referencing Ey...

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Celltrion Receives Health Canada Approval for Eydenzelt
November 28, 2025
FDA Approves Glaukos' Epioxa: First Incision-Free Corneal Cross-Linking Therapy for Keratoconus

The U.S. Food and Drug Administration (FDA) has approved Glaukos’ New Drug Application (NDA) for Epi...

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FDA Approves Glaukos' Epioxa: First Incision-Free Corneal Cross-Linking Therapy for Keratoconus
October 21, 2025
FDA Approves Celltrion’s Eylea Biosimilar Eydenzelt for Retinal Diseases

The U.S. Food and Drug Administration (FDA) has approved Eydenzelt (aflibercept-boav), a biosimilar ...

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FDA Approves Celltrion’s Eylea Biosimilar Eydenzelt for Retinal Diseases
October 13, 2025
FDA Approves Amneal Pharmaceuticals’ Generic Bimatoprost 0.01% for Glaucoma and Ocular Hypertension

Amneal Pharmaceuticals has received FDA approval for its Abbreviated New Drug Application (ANDA) for...

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FDA Approves Amneal Pharmaceuticals’ Generic Bimatoprost 0.01% for Glaucoma and Ocular Hypertension
September 25, 2025
FDA Accepts Idebenone for Priority Review as First Potential Treatment for LHON

The U.S. Food and Drug Administration (FDA) has accepted idebenone for priority review as a potentia...

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FDA Accepts Idebenone for Priority Review as First Potential Treatment for LHON
September 23, 2025
FDA Grants Fast Track Status to Sanofi’s Gene Therapy Candidate for Wet AMD

The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Sanofi’s investiga...

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FDA Grants Fast Track Status to Sanofi’s Gene Therapy Candidate for Wet AMD
September 12, 2025
FDA Clears IND for Opus Genetics’ OPGx-BEST1 Gene Therapy

Opus Genetics has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Admi...

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FDA Clears IND for Opus Genetics’ OPGx-BEST1 Gene Therapy
August 20, 2025
Lenz Therapeutics Secures FDA Approval for VIZZ for Presbyopia Treatment

Lenz Therapeutics has received U.S. FDA approval for VIZZ (aceclidine ophthalmic solution 1.44%), ma...

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Lenz Therapeutics Secures FDA Approval for VIZZ for Presbyopia Treatment
August 01, 2025
Precautionary Recall Announced for Specific Batch of Zaditen Eye Drops in the UK

A class 2 medicines recall has been issued in the United Kingdom for Zaditen 0.25 mg/ml eye drops so...

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Precautionary Recall Announced for Specific Batch of Zaditen Eye Drops in the UK
July 09, 2025
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