Morningstar

GC Biopharma Submits IND Application for Phase 1 Clinical Trial of COVID-19 mRNA Vaccine in Korea | Morningstar

YONGIN, South Korea, Sept. 22, 2025 /PRNewswire/ -- GC Biopharma (006280.KS), a leading South Korean pharmaceutical company, announced today that it has submitted an Investigational New Drug (IND) ...
Detroit Free Press

Aspire Biopharma Submits Pre-IND Meeting Request and Briefing Package to U.S. FDA for Sublingual Aspirin Product for Treatment of Suspected Acute Myocardial Infarction (Heart ...

ESTERO, FLORIDA / ACCESS Newswire / December 2, 2025 / Aspire Biopharma Holdings, Inc. (NASDAQ:ASBP) (“Aspire” or the “Company”), a developer of a multi-faceted patent-pending drug delivery technology ...
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 ...
Detroit Free Press

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 ...
Berkshire Eagle

GC Biopharma Secures IND Approval for Phase 1 Clinical Trial of COVID-19 mRNA Vaccine in Korea

YONGIN, South Korea, Dec. 22, 2025 /PRNewswire/ -- GC Biopharma (006280.KS), a leading global biopharmaceutical company, announced today that Ministry of Food and Drug Safety (MFDS) in South Korea has ...