Vyluma Meets with FDA on Atropine Sulfate Ophthalmic Solution 0.01% Under Development to Treat Pediatric Myopia
June 18, 2024 07:30 ET
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Vyluma, Inc.
Vyluma Discusses Response to FDA’s Questions and Clarifies Regulatory Pathway for its 505(b)(2) NDA, NVK002 to slow the progression of myopia in children.
Vyluma Announces Marketing Authorization Application Validation for the European Union
May 29, 2024 07:30 ET
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Vyluma, Inc.
Vyluma announces Marketing Authorisation Application (MAA) validation for the EU for NVK002 to slow the progression of pediatric myopia.
Vyluma Announces Positive Results From Second Stage of Phase III CHAMP Study of NVK002 for the Treatment of Myopia in Children
October 11, 2023 07:00 ET
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Vyluma, Inc.
BRIDGEWATER, N.J., Oct. 11, 2023 (GLOBE NEWSWIRE) -- Vyluma, Inc. (“Vyluma”), a biopharmaceutical company developing multiple assets for the treatment of refractive errors, announced today positive...
Vyluma Announces FDA Acceptance of New Drug Application for NVK002, Its Novel Investigational Treatment for Pediatric Myopia
June 06, 2023 07:00 ET
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Vyluma, Inc.
BRIDGEWATER, N.J., June 06, 2023 (GLOBE NEWSWIRE) -- June 6, 2023 – Vyluma, Inc. (“Vyluma”), a biopharmaceutical company developing multiple assets for the treatment of refractive errors, announced...
Vyluma to Present at the 41st Annual J.P. Morgan Healthcare Conference
January 05, 2023 07:00 ET
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Vyluma, Inc.
BRIDGEWATER, N.J., Jan. 05, 2023 (GLOBE NEWSWIRE) -- Vyluma, Inc. (“Vyluma”), a biopharmaceutical company developing multiple assets for the treatment of refractive errors, today announced it...
Vyluma Announces Positive Results From Phase III CHAMP Study of NVK002 for Treatment of Myopia Progression in Children
October 27, 2022 12:00 ET
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Vyluma, Inc.
BRIDGEWATER, N.J., Oct. 27, 2022 (GLOBE NEWSWIRE) -- Vyluma, Inc. (“Vyluma”), a biopharmaceutical company developing multiple assets for the treatment of refractive errors, today announced top-line...
Vyluma Completes Last Patient Visit for Primary Analysis of Pivotal Phase III CHAMP Study Evaluating NVK002 for the Treatment of Myopia Progression in Children
September 01, 2022 07:00 ET
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Vyluma, Inc.
BRIDGEWATER, N.J., Sept. 01, 2022 (GLOBE NEWSWIRE) -- Vyluma, Inc. (“Vyluma”), a biopharmaceutical company developing multiple assets for the treatment of refractive errors, announced today that the...