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...
La FDA Américaine Accorde la Qualification de Médicament Orphelin au PTX-252 pour le Traitement de la Leucémie Myéloïde Aiguë (LMA)
16 janv. 2024 13h30 HE
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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)
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...
Coherus Announces FDA Approval of UDENYCA ONBODY™, a Novel and Proprietary State-of-the-Art Delivery System for pegfilgrastim-cbqv
26 déc. 2023 16h01 HE
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Coherus BioSciences, Inc.
– Innovative design enables five-minute pegfilgrastim delivery time – – Unique, automatic, retractable needle mechanism engineered to maximize safety and comfort for cancer patients receiving...
FDA Approves Arcutis’ ZORYVE® (roflumilast) Topical Foam, 0.3% for the Treatment of Seborrheic Dermatitis in Individuals Aged 9 Years and Older
15 déc. 2023 17h11 HE
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Arcutis Biotherapeutics, Inc.
ZORYVE foam represents a highly effective, safe, well-tolerated, once-daily steroid-free foam for use on all affected areas of the body, including hair-bearing areas, with no limitations on duration...
Arch Biopartners Submits Application to Health Canada to Conduct the Phase II Cardiac Surgery Associated-Acute Kidney Injury Trial for LSALT Peptide
13 déc. 2023 07h25 HE
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Arch Biopartners
TORONTO, Dec. 13, 2023 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today it has submitted a Clinical Trial Application to...