OKYO Pharma Receives FDA Approval of IND for OK-101 in Neuropathic Corneal Pain
February 09, 2024 07:00 ET
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OKYO Pharma LTD
OK-101 is the first IND clearance granted by FDA for a drug to begin clinical studies specifically to treat patients suffering with neuropathic corneal pain (NCP), a major unmet medical needThe...
Optimi Announces Non-Brokered Private Placement
February 08, 2024 07:30 ET
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Optimi Health Corp.
Optimi Announces Non-Brokered Private Placement
Optimi Health To Host MDMA Educational Quality Assurance Webinar For Clinicians And Practitioners
February 06, 2024 07:30 ET
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Optimi Health Corp.
Highlights: Optimi Chief Science and Quality Assurance experts to provide in-depth access into the Company’s safety and quality standards.Optimi experts will address critical inquiries which still...
Qure.ai adds new FDA breakthrough device status to growing list of regulatory milestones
February 05, 2024 09:00 ET
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Qure.ai Technologies Private Limited
NEW YORK, Feb. 05, 2024 (GLOBE NEWSWIRE) -- Medical imaging AI innovator, Qure.ai, has received breakthrough device designation from the Food and Drug Administration's (FDA) Center for Devices and...
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 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...