While much attention has been given to approving a COVID-19 vaccine, there's been little paid to the facilities where many vaccines are manufactured. A recent investigation in Vanity Fair features a former FDA inspector turned whistleblower who says that the…
By Colleen Long, Associated Press
The coronavirus vaccine inching toward approval in the U.S. is desperately anticipated by Americans longing for a path back to normal life. But criminals are waiting, too. They're ready to use that desperation to their advantage.
By Linda A. Johnson, Associated Press
Two drugmakers say they have the go-ahead to resuming U.S. testing of their COVID-19 vaccine candidates. Both are in the final stage of testing before the companies can seek regulatory approval.
By Lauran Neergaard, Matthew Perrone, Associated Press
With vaccines against COVID-19 inching closer, U.S. regulators took an unusual step Thursday in asking outside scientists: Are the government's standards high enough to adequately judge the shots?…
By Helen Branswell, STAT
This week's meeting, while likely dry and technical, "shows the public that this is how FDA is going about its decisions," one expert said.
By Zeke Miller, Matthew Perrone, Associated Press
In briefing documents posted on its website, the FDA said vaccine makers should follow trial participants for at least two months to rule out safety issues before seeking emergency approval.
By Associated Press
Dr. Brett Giroir, an assistant secretary at the Department of Health and Human Services, told a Senate hearing he’d “have no hesitancy” to take that vaccine.
By Matthew Perrone, Ricardo Alonso-Zaldivar, Associated Press
First, the head of the Food and Drug Administration had to walk back exaggerated statements about the benefits of a new plasma therapy for coronavirus. Then the Centers for Disease Control and Prevention triggered a backlash from the medical community…
By Deb Reichmann, Matthew Perrone, Associated Press
Responding to outcries from medical experts, Food and Drug Administration Commissioner Stephen Hahn is admitting he overstated the life-saving benefits of treating COVID-19 patients with convalescent plasma.
By Linda A. Johnson, Associated PRess
Investors fled drug developer BioMarin in droves on Wednesday, driving shares down by a third after U.S. regulators rejected the company's potentially game-changing hemophilia A gene therapy.
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