News

FDA’s artificial intelligence is supposed to revolutionize drug approvals. It’s making up studies
Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...
FDA panel on the use of antidepressants during pregnancy is alarming experts
On Monday morning, the FDA hosted a 10-person expert panel on the use during pregnancy of SSRIs, which include medications ...
Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy
Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...
FDA Issues Risk Warning for Bread Recall Update
The FDA's assessment of the bread recall has designated it as a Class II risk, which means the product "may cause temporary ...
FDA names former pharmaceutical company executive to oversee US drug program
FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s ...
FDA appoints George Tidmarsh as top drug regulator
The U.S. Food and Drug Administration said on Monday it has appointed George Tidmarsh, a seasoned biotech executive and ...
FDA Issues Bread Recall Update After Glass Discovered in Crusts
For consumers, the FDA and Upper Crust Bakery LP advised that bread with affected lot numbers should not be consumed but ...
Biotech exec George Tidmarsh picked as FDA's chief drug regulator
The U.S. Food and Drug Administration named ex-biotech exec George Tidmarsh as its chief drug regulator. FDA Commissioner ...
FDA Elevates Dubai Chocolate Spread Recall to Class 1 Over Salmonella Risk
Salmonella can cause serious and potentially fatal infections in young children, the frail or elderly, and others with ...
FDA appoints biotech veteran George Tidmarsh to lead drug evaluation division
Stanford's George Tidmarsh has authored 143 scientific papers and patents, as well as played a central role in developing ...
FDA commissioner stirs debate over hormone therapy for menopause
A Food and Drug Administration (FDA) expert panel has reignited a debate over whether hormone therapy should be used to treat ...
FDA Approves Prefilled Syringe Presentation for Shingles Vaccine
Prefilled syringe eliminates the need to reconstitute separate vials prior to administration and simplifies the vaccine ...