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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
FDA Approves Expanded Label for Iluvien to Include Chronic Noninfectious Uveitis

The FDA has approved an expanded label for Iluvien, allowing its use for the treatment of chronic no...

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FDA Approves Expanded Label for Iluvien to Include Chronic Noninfectious Uveitis
March 17, 2025
Atsena Therapeutics Receives FDA Fast Track Designation for ATSN-201 Gene Therapy in X-Linked Retinoschisis

Atsena Therapeutics has been granted Fast Track designation by the FDA for ATSN-201, its investigati...

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Atsena Therapeutics Receives FDA Fast Track Designation for ATSN-201 Gene Therapy in X-Linked Retinoschisis
March 13, 2025
Sydnexis Announces FDA Acceptance of NDA for SYD-101 in Pediatric Myopia Treatment

Sydnexis has reached a significant regulatory milestone with the FDA’s acceptance of its New Drug Ap...

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Sydnexis Announces FDA Acceptance of NDA for SYD-101 in Pediatric Myopia Treatment
March 12, 2025
FDA Approves Revakinagene Taroretcel-Lwey (ENCELTO) for Macular Telangiectasia Type 2

The US Food and Drug Administration (FDA) has granted approval for revakinagene taroretcel-lwey (ENC...

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FDA Approves Revakinagene Taroretcel-Lwey (ENCELTO) for Macular Telangiectasia Type 2
March 07, 2025
FDA Approves Purified Cortrophin Gel Prefilled Syringe from ANI Pharmaceuticals

The US Food and Drug Administration (FDA) has approved ANI Pharmaceuticals’ Purified Cortrophin Gel ...

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FDA Approves Purified Cortrophin Gel Prefilled Syringe from ANI Pharmaceuticals
March 05, 2025
China Approves Zeiss Visumax 800 with SMILE Pro Software

Carl Zeiss Meditec AG, headquartered in Jena, Germany, has announced that its Visumax 800 femtosecon...

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China Approves Zeiss Visumax 800 with SMILE Pro Software
February 27, 2025
UK MHRA Approves Aflibercept Biosimilar FYB203 (AHZANTIVE) from Formycon

Formycon AG has received approval from the UK Medicines and Healthcare Products Regulatory Agency (M...

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UK MHRA Approves Aflibercept Biosimilar FYB203 (AHZANTIVE) from Formycon
February 26, 2025
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