Nurexone Biologic Initiates European Orphan Drug Designation Process Following U.S. Grant
February 02, 2024 16:05 ET
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NurExone Biologic Inc
Nurexone Biologic Initiates European Orphan Drug Designation Process Following U.S. Grant for its groundbreaking ExoPTEN product
Triastek's 3D Printed Gastric Retention Product T22 Receives FDA Clearance of IND Application
January 31, 2024 08:00 ET
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Triastek, Inc.
NANJING, CHINA, Jan. 31, 2024 (GLOBE NEWSWIRE) -- Triastek's 3D printed gastric retention product T22 received IND clearance from the FDA, becoming the world's first 3D printed gastric retention...
FDA Clears Magstim Transcranial Magnetic Stimulation System Horizon 3.0 with StimGuide Pro
January 30, 2024 09:18 ET
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Magstim EGI
FDA clears Magstim TMS System Horizon 3.0 with StimGuide Pro providing treatment for patients patients with depressive or obsessive-compulsive conditions
Theratechnologies reçoit une lettre de non-approbation (CRL) de la FDA concernant son supplément à la licence de produit biologique (sBLA) pour la formulation F8 de la tésamoréline
January 24, 2024 07:00 ET
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Theratechnologies
La FDA demande des clarifications sur la chimie, la fabrication et les contrôles ainsi que des informations supplémentaires sur l'immunogénicitéLa CRL n'affecte pas la disponibilité commerciale...
Theratechnologies Receives Complete Response Letter (CRL) from the FDA for the F8 Formulation of Tesamorelin sBLA
January 24, 2024 07:00 ET
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Theratechnologies
FDA requesting clarifications around chemistry, manufacturing and controls and additional information related to immunogenicityCRL does not impact commercial availability of EGRIFTA SV®, the F4...
Theratechnologies reçoit une mise à jour de la FDA concernant son supplément à la licence de produit biologique pour la formulation F8 de la tésamoréline
January 23, 2024 07:30 ET
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Theratechnologies
La FDA continue d'examiner le dossier après la date butoir du Prescription Drug User Fee Act fixée au 22 janvier 2024 MONTRÉAL, 23 janv. 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc....
Theratechnologies Receives Update from FDA on Tesamorelin F8 Supplemental Biologic License Application
January 23, 2024 07:30 ET
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Theratechnologies
FDA continues to review the file past the Prescription Drug User Fee Act goal date of January 22, 2024 MONTREAL, Jan. 23, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the...
60 Degrees Pharma Plans Pivotal Babesiosis Study with Tafenoquine Following Jan 17 FDA Meeting
January 22, 2024 07:59 ET
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Sixty Degrees Pharmaceuticals
Post-FDA meeting, 60 Degrees Pharma plans pivotal study of tafenoquine in hospitalized babesiosis patients, aiming to start in summer 2024. #biotech #SXTP
FDA grants global Medical Device company Biomimetic Innovations ‘Breakthrough Device’ designation for OsStic® Synthetic Injectable Structural Bio-Adhesive Bone Void Filler
January 19, 2024 10:15 ET
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Biomimetic Innovations Ltd
FDA grants global Medical Device company Biomimetic Innovations ‘Breakthrough Device’ designation for OsStic® Synthetic Injectable Structural Bio-Adhesive.
Optimi Health Secures Amendment to Increase Quantities Of MDMA, MDA, And 2C-B Under Controlled Drugs And Substances Dealer’s Licence
January 19, 2024 07:30 ET
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Optimi Health Corp.
Optimi Health granted amendment to its Health Canada Controlled Drugs and Substances Licence.