FDA – Discover Pharma

Welcome to Discover Pharma! Today is : April 20, 2026

FDA

Clinical Development,Drug Development,FDA,Neurosciences,Pharmaceuticals and therapeutics,Rare Diseases
Emalex wins US patent for ecopipam ODT as Tourette access program grows
Emalex has secured a US patent for an orally disintegrating [...]

April 17, 2026
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
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
Biotech,Clinical Development,Clinical Trials,Pharmaceuticals and therapeutics,Rare Diseases,Research & Development
Polaryx therapeutics selects contract research organization for SOTERIA phase 2 basket trial
Polaryx Therapeutics, Inc has selected a leading contract research organization [...]

February 18, 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
Clinical Development,Clinical Trials,Drug approval,Oncology,Pharmaceuticals and therapeutics,Rare Diseases,Regulatory Affairs
FDA accepts Merck NDA for pimicotinib in tenosynovial giant cell tumor
Merck has announced that the US Food and Drug Administration [...]

January 13, 2026
Cell & Gene Therapy,Oncology,Orphan drugs,Regulatory Affairs
Minovia Therapeutics gains FDA orphan drug designation for MNV-201 in myelodysplastic syndrome
Minovia Therapeutics has received orphan drug designation from the US [...]

October 17, 2025
Biologics & Biosimilars,Biotech,Clinical Development,Pharmaceuticals and therapeutics,Research & Development
FDA grants Fast Track designation to Enterome’s EO2463 immunotherapy in follicular lymphoma
Doron Therapeutics has dosed the first patients in its Phase [...]

October 17, 2025
Biologics & Biosimilars,Biotech,Chronic diseases,Clinical Development,Oncology,Pharmaceuticals and therapeutics,Research & Development
Enterome’s EO2463 receives FDA fast track designation for follicular lymphoma watch-and-wait treatment
Enterome has received Fast Track designation from the US Food [...]

October 17, 2025
Central Nervous System,Drug Development,Pharmaceuticals and therapeutics,Rare Diseases
FDA authorises Emalex Biosciences’ Expanded Access Program for Tourette syndrome drug
Emalex Biosciences has received FDA authorisation for an Expanded Access [...]

October 8, 2025