Fierce BiotechOpinion

‘A concerted industry-government effort’: Strand Therapeutics CEO Jake Becraft on FDA’s IND reform and China

For Jake Becraft, Ph.D., the future of America’s biomedical innovation isn’t just playing out in the lab—it's being shaped by ...

Telomir Pharmaceuticals Announces FDA Clearance of IND for Telomir-Zn in Triple-Negative Breast Cancer

Company Plans to Initiate First-in-Human Phase 1/2 Trial in 1H 2026, Anchored by a Leading U.S. Academic Medical ...
FierceBiotech

First FDA IND Milestone Achieved Using Human Vascularized Organoid Efficacy Data

World’s First IND Approval in Oncology Based Solely on Human Vascularized Organoid Efficacy Data Confirms Shift Toward Human-Relevant Preclinical Testing SAN DIEGO, Calif. – October 27, 2025 – ...
Morningstar

Pentixapharm Receives FDA "Study May Proceed" Letters for Dual Theranostic INDs in CXCR4-Based Hemato-Oncology Program

U.S. Investigational New Drug (IND) applications for radiotheranostic pair PentixaFor and PentixaTher became active following completion of the FDA 30-day review period. Proposed phase I/II trial ...
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 ...
Morningstar

EndoCyclic Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for ENDO-205, a First-in-Class Non-Hormonal Precision Peptide Therapeutic for ...

IRVINE, Calif., March 23, 2026 /PRNewswire/ -- EndoCyclic Therapeutics, a biopharmaceutical company developing precision peptide therapeutics and diagnostics for complex diseases, today announced that ...
Nasdaq

Enveric Biosciences Receives FDA Response and Streamlines Plans for EB-003 IND Submission

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company advancing next-generation neuroplastogenic small molecules to address ...
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 ...