Cingulate Reports Second Quarter 2024 Financial Results and Provides Development Update on Major Milestones Achieved
13 août 2024 07h45 HE
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Cingulate Inc.
FDA Clears Cingulate to File for Marketing Approval of CTx-1301 targeted in 1H 2025Licensing Activity Continues KANSAS CITY, Kan., Aug. 13, 2024 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a...
Phathom Pharmaceuticals Announces FDA Approval of VOQUEZNA® (vonoprazan) Tablets for the Relief of Heartburn Associated with Non-Erosive GERD in Adults
18 juil. 2024 08h00 HE
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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
16 juil. 2024 08h00 HE
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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
25 juin 2024 09h20 HE
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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
30 mai 2024 09h15 HE
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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
21 mai 2024 09h00 HE
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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
10 avr. 2024 12h04 HE
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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
22 mars 2024 10h59 HE
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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
16 févr. 2024 11h24 HE
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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...
Orphan Drug Designation Granted to PTX-252 by U.S. FDA for the Treatment of Acute Myeloid Leukaemia (AML)
16 janv. 2024 13h30 HE
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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...