Vyluma Meets with FDA on Atropine Sulfate Ophthalmic Solution 0.01% Under Development to Treat Pediatric Myopia
18 juin 2024 07h30 HE
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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
29 mai 2024 07h30 HE
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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
11 oct. 2023 07h00 HE
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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
06 juin 2023 07h00 HE
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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
05 janv. 2023 07h00 HE
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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
27 oct. 2022 12h00 HE
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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
01 sept. 2022 07h00 HE
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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...