Phathom Pharmaceuticals Announces Submission of Six-Month Stability Data in Support of Erosive GERD New Drug Application
21 août 2023 08h00 HE
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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
10 août 2023 08h01 HE
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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
12 juin 2023 08h01 HE
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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
01 juin 2023 08h00 HE
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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...
Phathom Pharmaceuticals Resubmits Erosive GERD New Drug Application to FDA
23 mai 2023 16h00 HE
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Phathom Pharmaceuticals
Anticipated FDA action date in Q4 2023; if approved, combined launch for Erosive GERD and H. pylori indications planned before year endIf approved, vonoprazan would be the first innovative acid...
Phathom Pharmaceuticals Reports First Quarter 2023 Results
10 mai 2023 08h00 HE
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Phathom Pharmaceuticals
FLORHAM PARK, N.J., May 10, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for...
Phathom Pharmaceuticals Presents New Data at Digestive Disease Week® (DDW) 2023
09 mai 2023 08h00 HE
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Phathom Pharmaceuticals
Higher H. pylori eradication rates demonstrated with vonoprazan-based regimens vs. lansoprazole triple therapy, regardless of different baseline demographics and clinical characteristicsMeta-analysis...
Phathom Pharmaceuticals to Participate in Upcoming Investor Conferences
12 avr. 2023 08h00 HE
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Phathom Pharmaceuticals
FLORHAM PARK, N.J., April 12, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for...
Phathom Pharmaceuticals Announces Regulatory Update and Plans for 2023 Erosive Esophagitis and H. pylori Commercial Launch
04 avr. 2023 08h00 HE
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Phathom Pharmaceuticals
Favorable feedback following meeting with the U.S. Food and Drug Administration (FDA) allows for planned resubmission of erosive esophagitis new drug application (NDA) this quarterCombined commercial...
Phathom Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update
28 févr. 2023 08h00 HE
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Phathom Pharmaceuticals
Meeting scheduled in March 2023 with the U.S. Food and Drug Administration (FDA) to discuss stability data and resubmission requirements for erosive GERD and H. pylori New Drug Applications FLORHAM...