MAPS Successfully Clears Path for Cannabis Research through FDA Formal Dispute
November 20, 2024 12:40 ET
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Multidisciplinary Association for Psychedelic Studies (MAPS)
After three years of negotiation with the FDA, MAPS has successfully secured FDA clearance to conduct a clinical trial, MJP2, to examine the use of smoked cannabis for the treatment of PTSD symptoms...
PharmaTher Announces Update on FDA New Drug Application for Ketamine
November 19, 2024 08:00 ET
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PharmaTher Holdings Ltd.
FDA granted a post-complete letter clarification meeting scheduled for December 2, 2024 Company initiated activities to address the deficiencies cited in the CRL TORONTO, Nov. 19, 2024 (GLOBE...
Siren Biotechnology Reveals SRN-101 as Lead Asset for High-Grade Gliomas with Both Orphan Drug and Rare Pediatric Disease Designations from the FDA
November 18, 2024 11:00 ET
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Siren Biotechnology, Inc.
Siren Biotechnology reveals SRN-101 as lead asset for high-grade gliomas with both Orphan Drug and Rare Pediatric Disease Designations from the FDA
Dogwood Therapeutics, Inc. Announces Low Dose IMC-2 Treatment Reduces Long-COVID Related Fatigue and Sleep Disturbance in an Investigator-Initiated Study
November 18, 2024 08:45 ET
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Dogwood Therapeutics, Inc.
- IMC-2 treatment, dosed as valacyclovir 750 mg + celecoxib 200 mg twice daily, demonstrated clinically meaningful reduction in Long-COVID related fatigue and sleep disturbance as compared to placebo...
Lexeo Therapeutics Provides Update on Cardiac Portfolio and Reports Third Quarter 2024 Financial Results
November 13, 2024 07:30 ET
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Lexeo Therapeutics
Lexeo Therapeutics Provides Update on Cardiac Portfolio and Reports Third Quarter 2024 Financial Results
FDA Clears Magstim Horizon INSPIRE Transcranial Magnetic Stimulation System to treat Depression, OCD, Anxious Depression
November 12, 2024 08:11 ET
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Magstim EGI
FDA clears Magstim INSPIRE Transcranial Magnetic Stimulation TMS system to treat patients with Depression, OCD, Anxious Depression
Acuitive Technologies Receives FDA 510(k) Clearance for CITREPORE™, A New Synthetic Bioactive Bone Void Filler for Orthopedic Procedures
November 12, 2024 08:00 ET
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Acuitive Technologies
Acuitive Technologies announced the FDA 510(k) clearance of CITREPORE™, a new synthetic bioactive bone void filler for orthopedic procedures.
Autolus Therapeutics Announces FDA Approval of AUCATZYL® (obecabtagene autoleucel – obe-cel) for adults with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)
November 08, 2024 16:23 ET
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Autolus Therapeutics plc
Autolus Therapeutics Announces FDA Approval of AUCATZYL® (obe-cel) for adults with relapsed/refractory B-cell acute lymphoblastic leukemia
CytoSorbents Reports Third Quarter 2024 Financial and Operational Results
November 07, 2024 16:05 ET
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CytoSorbents
PRINCETON, N.J., Nov. 07, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery...
CytoSorbents Submits Health Canada Medical Device License Application for DrugSorb-ATR Following MDSAP Certification
November 04, 2024 07:00 ET
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CytoSorbents
CytoSorbents submits DrugSorb-ATR Medical Device License Application to Health Canada following MDSAP Certification. Expects regulatory decision in 2025