Quantum BioPharma Submits Investigational New Drug (IND) Application to United States Food and Drug Administration (FDA) for Lucid-MS Phase Two Clinical Trial in Multiple Sclerosis

The IND submission includes data from nonclinical pharmacology and toxicology studies, along with manufacturing and quality information, to support initiation of the planned Phase 2 clinical trial.
Morningstar

Mandara Biopharma Files IND with the FDA to Advance Dronabinol Oral Solution Formulation for Alzheimer's Agitation

BOULDER, Colo., Jan. 12, 2026 /PRNewswire/ -- Mandara Biopharma Inc., a privately held U.S.-based biopharmaceutical company focused on novel therapies for central nervous system (CNS) disorders, today ...
Nasdaq

Kiromic BioPharma Announces FDA Authorization of IND to Initiate Phase 1 Clinical Trial Evaluating Deltacel in Non-Small Cell Lung Cancer

HOUSTON--(BUSINESS WIRE)-- Kiromic BioPharma, Inc. (NASDAQ: KRBP) (“Kiromic” or the “Company”), a clinical-stage, fully-integrated biotherapeutics company using its proprietary DIAMOND® artificial ...
Nasdaq

Cue Biopharma Receives FDA Pre-IND Feedback for CUE-401, a Novel Therapeutic Aimed at Autoimmune Diseases

Cue Biopharma, Inc. has announced that it has received positive Pre-Investigational New Drug (Pre-IND) feedback from the FDA regarding its planned first-in-human trial for CUE-401, a novel bispecific ...
GEN - Genetic Engineering and Biotechnology News

Biopharma Benefitting from AI in Manufacturing

AI is already helping the biopharmaceutical industry to optimize its manufacturing activities, according to IFPMA.