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New drug application (NDA) seeks U.S. Food and Drug Administration (FDA) approval for VOQUEZNA® as a daily treatment for heartburn associated with Non-Erosive GERD, the largest subcategory of GERDJuly...
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VOQUEZNA, the first and only FDA-approved potassium-competitive acid blocker (PCAB), is now available at major retail pharmacies and through BlinkRx.
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VOQUEZNA® (vonoprazan) tablets approved by the U.S. Food and Drug Administration (FDA) for the treatment of Erosive GERD and relief of associated heartburn in adults, marking the first major...
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FDA approval marks the first major innovation to the U.S. Erosive GERD market in over 30 yearsVOQUEZNA® met the primary endpoints and key secondary superiority endpoints in the pivotal Phase 3...
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Planning for a December 2023 U.S. launch for H. pylori, together with the U.S. launch of vonoprazan for Erosive GERD, if approved FLORHAM PARK, N.J., Oct. 30, 2023 (GLOBE NEWSWIRE) -- Phathom...
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FLORHAM PARK, N.J., Oct. 25, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for...
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Submission based on positive results from Phase 3 PHALCON-NERD-301 in which vonoprazan 10 mg and 20 mg controlled heartburn symptoms through the entire 6 months of the study with a safety profile...
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FLORHAM PARK, N.J., Sept. 05, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for...
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Six-month stability data remain more than 10x below the acceptable intake limit set by the U.S. Food and Drug Administration (FDA) and continue to support the requested product shelf lifeSubmission of...
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Prior Approval Supplement (PAS) for VOQUEZNA® TRIPLE PAK® and VOQUEZNA® DUAL PAK® assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 30, 2023 by the U.S. Food and Drug...