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.
Seeking Alpha

Context Therapeutics Announces FDA Clearance of IND Application for a Phase 1 Clinical Trial of CTIM-76

PHILADELPHIA, May 02, 2024 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (CNTX), a biopharmaceutical company advancing medicines for solid tumors, today announced that the U.S. Food and Drug ...
Healio

FDA accepts IND for synthetic psilocybin therapeutic to treat PTSD

Please provide your email address to receive an email when new articles are posted on . The acceptance paves the way for a pending phase 2b/3 clinical trial of COMP360 in PTSD. The manufacturer plans ...
The Scientist

IND Applications Are Tedious. Can AI Help?

In August 2024, Bin Xia Yang, a portfolio director at the pharmaceutical company Axcynsis Therapeutics, geared up to move the company’s new tumor-fighting antibody-drug conjugate into clinical trials.
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 ...
USA Today

Aspire Biopharma Announces Successful Pre-IND Meeting with FDA for High-Dose Sublingual Aspirin (OTASA)

FDA feedback supports 505(b)(2) filing in H2 2026; No additional studies required beyond current planned 32-subject clinical trial ESTERO, FL / ACCESS Newswire / January 7, 2026 / Aspire Biopharma ...