Phathom Pharmaceuticals Announces FDA Approval of VOQUEZNA® (vonoprazan) Tablets for the Relief of Heartburn Associated with Non-Erosive GERD in Adults
July 18, 2024 08:00 ET
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Phathom Pharmaceuticals
VOQUEZNA is now approved and available to treat the largest category of Gastroesophageal Reflux Disease (GERD)
Annovis Bio Receives FDA Approval to Transition to New Crystal Form of Buntanetap
July 16, 2024 08:00 ET
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Annovis Bio, Inc.
MALVERN, Pa., July 16, 2024 (GLOBE NEWSWIRE) -- via IBN – Annovis Bio Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies...
Cingulate Achieves Key Manufacturing Milestone in the Development of its ADHD Drug CTx-1301 in Preparation for FDA Marketing Clearance
June 25, 2024 09:20 ET
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Cingulate Inc.
Twelve Required Registration Batches CompletedNew Drug Application Being Prepped for Submission KANSAS CITY, Kan., June 25, 2024 (GLOBE NEWSWIRE) -- In alignment with U.S. Food and Drug...
AVITA Medical Announces FDA Approval of RECELL GO
May 30, 2024 09:15 ET
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AVITA Medical
AVITA Medical receives FDA approval for RECELL GO, its next-generation device used to treat thermal burn wounds and full thickness skin defects.
FDA Clears Cingulate to File for Marketing Approval of CTx-1301 in the Treatment of ADHD
May 21, 2024 09:00 ET
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Cingulate Inc.
Phase 3 Data Collected to Date Sufficient for Submission of New Drug Application
Advancing Discussions with Commercialization Partners
Raydiant Oximetry Secures FDA Approval for Lumerah Investigational Device Exemption (IDE) Study
April 10, 2024 12:04 ET
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Raydiant Oximetry
The FDA has approved the Investigational Device Exemption (IDE) of Lumerah for an Early Feasibility Study (EFS) of pregnant women during labor and delivery
FDA Clears RedDrop Dx, Inc.’s Blood Collection Device, RedDrop One
March 22, 2024 10:59 ET
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Innosphere Ventures
Fort Collins, CO, March 22, 2024 (GLOBE NEWSWIRE) -- RedDrop Dx, Inc., Innosphere Ventures Client Company, is pleased to announce that its innovative blood collection device, RedDrop One, has...
FDA approves Xolair as first and only medicine for children and adults with one or more food allergies
February 16, 2024 11:24 ET
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F. Hoffmann-La Roche Ltd
Approval is based on data from the NIH-sponsored Phase III OUtMATCH study, which showed a significantly higher proportion of food allergy patients as young as 1 year treated with Xolair could tolerate...
La FDA Américaine Accorde la Qualification de Médicament Orphelin au PTX-252 pour le Traitement de la Leucémie Myéloïde Aiguë (LMA)
January 16, 2024 13:30 ET
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Hyloris Pharmaceuticals SA
La FDA Américaine Accorde la Qualification de Médicament Orphelin au PTX-252 pour le Traitement de la Leucémie Myéloïde Aiguë (LMA) Le PTX-252 (précédemment appelé agent plécoïdeTM) est une nouvelle...
Orphan Drug Designation Granted to PTX-252 by U.S. FDA for the Treatment of Acute Myeloid Leukaemia (AML)
January 16, 2024 13:30 ET
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Hyloris Pharmaceuticals SA
Orphan Drug Designation Granted to PTX-252 by U.S. FDA for the Treatment of Acute Myeloid Leukaemia (AML) PTX-252 (previously referenced as a Plecoid™Agent) is a novel molecular entity developed in...