FDA – Discover Pharma

Welcome to Discover Pharma! Today is : March 26, 2026

FDA

Clinical Development,Clinical Trials,Drug Development,FDA,Infectious Diseases
PolyPid prepares D-PLEX100 NDA following Phase 3 surgical infection data
PolyPid is preparing to submit a New Drug Application for [...]

March 18, 2026
Biotech,Clinical Trials,FDA,Hematology,Rare Diseases,Regulatory Affairs
Hemab Therapeutics wins FDA breakthrough therapy status for sutacimig in Glanzmann thrombasthenia
The FDA has granted breakthrough therapy designation to Hemab [...]

March 5, 2026
Biologics & Biosimilars,Biomanufacturing,Biotech,Clinical Development,Clinical Trials,Drug approval,Drug Development,FDA,Rare Diseases,Research & Development
Hansa Biopharma’s BLA for imlifidase accepted by FDA
Hansa Biopharma’s Biologics License Application (BLA) for imlifidase has been [...]

February 19, 2026
Clinical Trials,FDA,Mental health,Neurosciences,Pharmaceuticals and therapeutics
Compass Pathways reports positive second Phase 3 trial for COMP360 in treatment-resistant depression
Compass Pathways has reported that its second pivotal Phase 3 [...]

February 18, 2026
Central Nervous System,Clinical Development,Clinical Trials,Drug Development,FDA,Pharmaceuticals and therapeutics,Precision medicine,Research & Development
Alto Neuroscience completes Phase 2 enrollment for ALTO-101 in cognitive impairment associated with schizophrenia
Alto Neuroscience has completed patient enrollment in its Phase 2 [...]

February 13, 2026
Biologics & Biosimilars,Clinical Development,Drug approval,FDA,Funding,Pharmaceuticals and therapeutics,Rare Diseases,Regulatory Affairs
Hansa Biopharma reports 135% Q4 revenue growth and BLA submission for imlifidase
Hansa Biopharma has reported a 135% increase in fourth-quarter revenue [...]

February 13, 2026
Drug Development,FDA,Movers & Shakers,Precision medicine,Research & Development
VoxCell appoints chief commercial officer as demand grows for predictive non-clinical models
VoxCell, a Canadian biotechnology company developing vascularized 3D tissue models, [...]

January 27, 2026
Digital Health,FDA,Medical devices,Mental health
FDA approves first at-home non-drug treatment for depression
US regulators have authorised the first at-home brain-stimulation treatment for [...]

December 12, 2025

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