Silo Pharma Announces Completion of FDA Pre-IND Meeting to Advance Development of SPC-15 for Treatment of PTSD
Proposal submitted for FDA 505(b)(2) regulatory pathway for SPC-15 approvalAdvancing path to IND submission for first-in-human trialsSARASOTA, ...
BriaCell Therapeutics Corp.: BriaCell Announces Positive Pre-IND Meeting with FDA for Bria-PROS+ for Prostate Cancer
BriaCell has received positive feedback from its Pre-Investigational New Drug Application (Pre-IND) meeting with FDA for Bria-PROS+ in prostate cancerThe meeting provides a clear path towards filing ...
Targeted Oncology1d
FDA Clears Investigational New Drug Application for CD-001 in Oncology
Following an investigational new drug application clearance from the FDA, a phase 1 trial plans to evaluate CD-001.
Nature13d
Transporters in drug development: advancing on the Critical Path
A new report ... a certain drug interaction is not present or expected. As the field of membrane transporter research is evolving rapidly, transporter-specific information in NDA submissions ...
GENFIT Reports First Half-Year 2024 Financial Results and Provides Corporate Update
Cash and cash equivalents totaled €61.6 million as of June 30, 2024, excluding the €48.7 million milestone invoiced in June 2024 (received in ...
GENFIT S.A.: GENFIT Reports First Half-Year 2024 Financial Results and Provides Corporate Update
Cash and cash equivalents totaled €61.6 million as of June 30, 2024, excluding the €48.7 million milestone invoiced in June 2024 (received in August 2024) upon first sale of Ipsen's Iqirvo® (elafibran ...
Reuters23d
Federal Regulation of Psychedelic Therapies
(For more on the NDA approval process, see Investigational New Drug Application Checklist on ... arguing that the CSA must accommodate a path to legally accessing the substance under the ...
Pharmabiz25d
Tonix Pharma and Bilthoven Biologicals collaborate on advancing development of Tonix’s mpox vaccine, TNX-801
Tonix has received official written response from a Type B pre-Investigational New Drug Application (IND ... Tonix believes the FDA feedback provides a path to agreement on the design of a phase 1/2 ...