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FDA Issues Updated Guidance on Expanded Access to Investigational Drugs

The U.S. Food and Drug Administration (FDA) has issued updated guidance on Expanded Access to Investigational Drugs for Treatment Use, clarifying how drug developers, physicians, and patients can ...

GNTbm's self-developed anti-cancer new drug GNTbm-38 has obtained IND approval from the U.S. FDA for Phase I clinical trials

Great Novel Therapeutics Biotech & Medicals Corporation (GNTbm) (stock code: 7427) announced that its independently developed novel epigenetic immunoactivator GNTbm-38, with global rights for cancer ...

FDA Issues Landmark Biosimilar Guidance Incorporating Regulatory Reforms Advised by Professor Niazi: Further Cutting Development Costs by Up to 50%

The U.S. Food and Drug Administration (FDA) today released New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4)1, a sweeping guidance that codifies multiple regulatory ...
Seeking Alpha

Atossa Therapeutics Announces Positive FDA Feedback, Advances Toward IND for (Z)-Endoxifen Clinical Program in ER+/HER2- Metastatic Breast Cancer

SEATTLE, July 29, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (ATOS), a clinical-stage biopharmaceutical company developing innovative medicines in oncology, today announced positive written ...
Nasdaq

Aclaris Therapeutics Secures U.S. Food and Drug Administration IND Clearance for ATI-052, Enabling Advancement of its Novel Bispecific Anti-TSLP/IL-4R Investigational Antibody

WAYNE, Pa, April 22, 2025 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for ...
Daily Record

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 ...
Drug Target Review

Navigating IND delays: strategic options for early-phase biotech development

Understand the impact of IND delays on biotechnology companies and how they affect early-stage development and funding.