As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...

Calgary, Alberta –TheNewswire -May 22, 2025- Ocumetics Technology Corp (OTCFF). (FRA: 2QBO), a leader in advanced ophthalmic technology, is pleased to announce the submissionof its first-in-human (FIH ...

In the past few years, the healthcare world has faced some of its toughest challenges the COVID-19 pandemic was a wake up call for everyone especially for those involved in clinical trials many trials ...

The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...

MELVILLE, N.Y., April 16, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based ...

The U.S. FDA’s draft guidance for reporting of deviations from clinical study protocols lends some insight as to the definition of a deviation, but the agency highlights some concerns about related ...

HIGH POINT, N.C., Dec. 18, 2025 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company, today announced a Phase 2 clinical study protocol developed in ...

At this year's conference, TransCelerate and representatives from its member companies, including Amgen, Merck, and Pfizer, will participate in seven sessions addressing topics such as data collection ...