News

100 days into the job, FDA head talks to CNN about agency goals— and Coke’s switch to sugar
Marty Makary says the FDA will plow ahead with big plans on ultra processed foods, dietary guidelines, and expedited drug and ...
FDA Layoffs Could Compromise Safety of Medications Made at Foreign Factories, Inspectors Say
For years, inspectors have uncovered dirty equipment, contaminated supplies and fraudulent testing records in some overseas factories — serious safety and quality breaches that can sicken or kill ...
BioPharma Dive2d
Former biotech executive appointed to lead FDA drug office
George Tidmarsh, a Stanford University physician who founded Horizon Pharma and later ran La Jolla Pharma, was named head of ...
STAT18d
Inside the staff exodus and tanking morale that threaten Makary’s FDA
WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...
Becker's Hospital Review17d
Drug inspectors warn of slower checks following FDA layoffs
Cuts at the FDA are slowing inspections of overseas drug manufacturers, prompting concerns from former and current employees that medication safety could be at risk, ProPublica reported July 7. Dozens ...
Fierce Pharma4d
Sarepta stands behind Elevidys after FDA requests gene therapy be pulled from market
As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm ...
BioSpace10d
HHS Begins Formally Laying Off Employees
Thousands of employees across HHS were terminated Monday evening after the U.S. Supreme Court ruled last week that the Trump ...
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 Center for Drug Evaluation and Research, which regulates the safety and ...
Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys
U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...
MM&M18d
FDA layoffs could compromise safety of medications made at foreign ...
At the time, the agency said the reductions would not impact inspectors. Kennedy has since announced that HHS would reverse 20% of the cuts across the agency. Amid news reports describing the layoffs ...