Phathom Pharmaceuticals Announces FDA Acceptance for Filing of VOQUEZNA® (vonoprazan) Tablets New Drug Application for the Treatment of Heartburn Associated with Non-Erosive GERD
December 06, 2023 08:00 ET
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Phathom Pharmaceuticals
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...
Phathom Pharmaceuticals Announces Commercial Availability of VOQUEZNA® (vonoprazan) Tablets, a Powerful First-In-Class PCAB for the Treatment of Erosive GERD and Relief of Associated Heartburn
November 28, 2023 08:00 ET
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Phathom Pharmaceuticals
VOQUEZNA, the first and only FDA-approved potassium-competitive acid blocker (PCAB), is now available at major retail pharmacies and through BlinkRx.
Sosei Heptares and Kallyope Nominate First GPCR Target for Therapeutic Development in Gastrointestinal Diseases
November 10, 2023 01:35 ET
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Sosei Group Corporation
Tokyo, Japan, Cambridge, UK and New York, USA – 10 November 2023 – Sosei Group Corporation (“Sosei Heptares”; TSE: 4565), the international biopharmaceutical company, and Kallyope, a clinical stage...
Phathom Pharmaceuticals Reports Third Quarter 2023 Results and Recent Business Updates
November 09, 2023 08:00 ET
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Phathom Pharmaceuticals
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...
Phathom Pharmaceuticals Announces Vonoprazan NDA Submission for Non-Erosive GERD
September 26, 2023 08:01 ET
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Phathom Pharmaceuticals
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...
Phathom Pharmaceuticals to Participate in Upcoming Investor Conferences
September 05, 2023 08:00 ET
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Phathom Pharmaceuticals
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...
Phathom Pharmaceuticals Announces Submission of Six-Month Stability Data in Support of Erosive GERD New Drug Application
August 21, 2023 08:00 ET
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Phathom Pharmaceuticals
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...
Phathom Pharmaceuticals Reports Second Quarter 2023 Results
August 10, 2023 08:01 ET
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Phathom Pharmaceuticals
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...
Phathom Pharmaceuticals Announces FDA Acceptance of NDA Resubmission for Erosive GERD
June 12, 2023 08:01 ET
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Phathom Pharmaceuticals
Prescription Drug User Fee Act (PDUFA) goal date of November 17, 2023Combined launch of vonoprazan for Erosive GERD and H. pylori indications planned for Q4 2023, if approved FLORHAM PARK, N.J., June...
Phathom Pharmaceuticals to Participate in Upcoming Investor Conferences
June 01, 2023 08:00 ET
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Phathom Pharmaceuticals
FLORHAM PARK, N.J., June 01, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for...