News

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 commissioner stirs debate over hormone therapy for menopause
A Food and Drug Administration expert panel has reignited a debate over whether hormone therapy should be used to treat ...
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 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 Approves Prefilled Syringe Presentation for Shingles Vaccine
Prefilled syringe eliminates the need to reconstitute separate vials prior to administration and simplifies the vaccine ...
MedPage Today23h
Drugmaker Refuses FDA's Request to Pull Gene Therapy Tied to Patient Deaths
The agency also revoked Sarepta's platform technology designation for AAVrh74 Friday and issued a safety communication saying ...
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 Suspends Muscular Dystrophy Drug After 3 Patient Deaths
The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...
FDA appoints biotech executive as top drug regulator under RFK Jr.
Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the agency’s ...
FDA to appoint George Tidmarsh as top drug regulator, Bloomberg News reports
U.S. Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the ...