News

Public Broadcasting Service (PBS)32m
WATCH LIVE: RFK Jr. makes ‘major announcement’ with FDA and International Dairy Foods Association
Agriculture Secretary Brooke Rollins and Health and Human Services Secretary Robert F. Kennedy Jr. will hold a news briefing ...
Stars Insider on MSN20m
FDA issues alert, recall for contaminated blueberries
On July 1, the FDA upgraded its recall of Alma Pak organic blueberries to Class I—the highest alert—after Listeria ...
GSK seeks FDA nod for expanded use of RSV vaccine in adults
British drugmaker GSK said on Monday it had submitted an application to the U.S. Food and Drug Administration to extend the ...
BioPharma Dive6m
FDA rejects Ultragenyx gene therapy over manufacturing concerns
While the complete response letter derails a near-term clearance, one analyst described the rejection as more of “a speed ...
Fierce Pharma1h
Ultragenyx takes another hit as FDA snubs AAV gene therapy over manufacturing issues
The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...
Mushrooms are being recalled over Listeria fears in two separate FDA notices: Avoid these products
Needle mushrooms and other mushroom products are impacted by two separate recall notices from the Food and Drug ...
FDA rejects Ultragenyx rare disease gene therapy around manufacturing issues
A rare metabolic condition affecting children may have to wait longer for a potential one-time treatment as Ultragenyx ...
Physicians Committee for Responsible Medicine3h
A Turning Point: FDA and NIH Commit to Reducing Animal Testing
The Food and Drug Administration (FDA), in collaboration with the National Institutes of Health (NIH), hosted a workshop ...
STAT3hOpinion
The FDA commissioner is a gifted talker — but the job is about more than that
FDA Commissioner Marty Makary's vision for the agency risks the best of an agency that mostly has functioned well for the ...
Capricor Therapeutics: Buying Opportunity Following FDA's Complete Response Letter
Capricor Therapeutics's dip caused by the CRL is a buying opportunity considering the readout of HOPE-3 within 2-3 months.
The American Journal of Managed Care3h
FDA Approves Finerenone for Heart Failure With Mildly Reduced or Preserved LVEF
Finerenone gained FDA approval for heart failure treatment, showcasing significant benefits in reducing cardiovascular events ...
National Law Review1h
FDA: Commissioner’s National Priority Voucher Program Aims to Streamline Some Drug Reviews
The U.S. Food and Drug Administration (FDA) recently announced a new Commissioner’s National Priority Voucher (CNPV) program, ...