OS Therapies gears up for FDA meeting on cancer drug
NEW YORK - OS Therapies, Inc. (NYSE-A: OSTX), a small-cap biotech firm with a market capitalization of $42 million focusing on cancer treatment solutions, has announced the completion of its Phase 2b ...
JD Supra2d
A Model’s Credibility Is in the Details: FDA Draft Guidance on the Use of AI Models in Drug and Biological Product Development
In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) models in ...
The American Journal of Managed Care8d
Evolent’s Wonsettler Sees Outcomes-Based Reimbursement as “A Healthy Tool”
Terra Wonsettler, PharmD, MBA, vice president of pharmacy for Evolent, discusses the recent HHS OIG report that stemmed from ...
Food Safety News12d
Legislators want the FDA to be able to test samples from feed lots during outbreaks
Two U.S. legislators have introduced a bill that would give the FDA the ability to collect microbial samples at feed lots during foodborne illness ...
Fox News14d
FDA recalls breadcrumbs sold nationwide
The FDA published it three days later, on the 28th. The recalled products include 8-ounce packages of La Fiesta brand "Unseasoned Bread Crumbs (Pan Rayado)" and "Seasoned Bread Crumbs (Pan Rayado ...
Putnam Daily Voice15d
FDA Approves First Non-Opioid Painkiller In 20+ Years: 'A Historic Milestone'
Journavx received FDA approval, the agency announced on Thursday, Jan. 30. The drug developed by Boston-based Vertex Pharmaceuticals blocks sodium channels in the peripheral nervous system, preventing ...
Yahoo Finance16d
Karolinska Development’s portfolio company Dilafor advances tafoxiparin following successful meetings with FDA and European regulatory authorities
Positive outcomes from scientific advice meetings with the FDA and the EMA, were followed by a Simultaneous National Scientific Advice, SNSA, including five key national EU authorities ...
Mena FN17d
FDA Inspections Seminar: Fundamentals And The Ground Rules On How To Prepare For And Survive An FDA Inspection (ONLINE EVENT: February 24-25, 2025)
(MENAFN- GlobeNewsWire - Nasdaq) Dublin, Jan. 30, 2025 (GLOBE NEWSWIRE) -- The "FDA Inspections: From Site Preparation to Response" training has been added to ResearchAndMarkets.com's offering.
Yahoo Finance17d
FDA Inspections Seminar: Fundamentals and the Ground Rules on How to Prepare for and Survive an FDA Inspection (ONLINE EVENT: February 24-25, 2025)
Dublin, Jan. 30, 2025 (GLOBE NEWSWIRE) -- The "FDA Inspections: From Site Preparation to Response" training has been added to ResearchAndMarkets.com's offering. This is a practical, hands-on two-day ...