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 ...

PDS Biotech Announces Scheduling of Type C Meeting with U.S. Food and Drug Administration (“FDA”)

Company to Discuss Proposed Amendment to Phase 3 VERSATILE-003 Trial Enabling Potential Accelerated Approval PathwayPRINCETON, N.J., Dec. 02, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation ...
BioSpace

Imvax Heads to FDA With 6-Month Survival Gain in Glioblastoma, Despite Endpoint Miss

While Imvax’s autologous immunotherapy IGV-001 missed the primary endpoint of progression-free survival in a Phase IIb trial, ...
TipRanks on MSN

Aspire Biopharma submits pre-IND meeting request to FDA for sublingual aspirin

Aspire Biopharma (ASBP) announced that on November 3, 2025, it submitted its Pre-IND meeting request and briefing package to the U.S. Food and ...

FDA Pilots Faster Clarifications to Meeting Minutes

Specifically, sponsors will be able to submit a question via email and agency staff will aim to respond within three business days by email. Since the pilot launched in October, the agency has ...
BioSpace

FDA Rolls Out Agentic Models in Bid to ‘Modernize’ Regulatory Workflows

Agentic AI can help FDA staff manage meetings, conduct pre-market reviews and validate reports, among other tasks, though the ...
Fierce Biotech

FDA issues draft guidance to reduce primate testing for certain antibodies

The FDA encourages sponsors to discuss plans to use animal testing alternatives, called new approach methodologies or NAMs, ...