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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
Glaukos Announces FDA Acceptance of NDA Submission for Epioxa

Glaukos has received notification from the U.S. Food and Drug Administration (FDA) confirming accept...

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Glaukos Announces FDA Acceptance of NDA Submission for Epioxa
February 25, 2025
FDA Clears New World Medical's VIA360 Surgical System for Ophthalmic Procedures

New World Medical has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for...

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FDA Clears New World Medical's VIA360 Surgical System for Ophthalmic Procedures
February 19, 2025
FDA Accepts Biologics License Application for AVT06, Alvotech’s Biosimilar to Eylea

Alvotech and Teva Pharmaceuticals have announced that the U.S. Food and Drug Administration (FDA) ha...

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FDA Accepts Biologics License Application for AVT06, Alvotech’s Biosimilar to Eylea
February 19, 2025
FDA Approves Amended Label for Izervay in the Treatment of Geographic Atrophy

The FDA has approved an amended label for avacincaptad pegol intravitreal solution (Izervay; Astella...

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FDA Approves Amended Label for Izervay in the Treatment of Geographic Atrophy
February 14, 2025
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