The agency approved Gilead’s “game changer” hepatitis C cure, bypassing concerns raised by its own federal inspectors. The problems they found at the company’s main U.S. drug-testing laboratory in Foster City, Calif., were so bad, they recommended withholding approval.
Doctors who saw patients with a mysterious lung illness in the past suspected vaping as the cause but didn’t know where to report such cases. “It wasn’t that I didn’t want to report it, it’s that there’s no pathway,” said one California pulmonologist.
Known as “authorized generics,” in-house spinoffs of brand-name drugs quietly undermine the competition.
The Food and Drug Administration released two decades of previously hidden data containing millions of injuries or malfunctions by medical devices. Here’s what we’ve learned so far.
The FDA reveals that 56,000 malfunctions associated with surgical staplers weren’t reported through its traditional public reporting system.
As part of his plan to tamp down drug pricing, President Donald Trump wants pharmaceutical companies to provide cost information in drug ads — just like side effects.
What to know about PBMs and rebates ahead of the Senate drug price hearing on — you guessed it — PBMs.
A Kaiser Health News database shows that $58 million flowed from drugmakers to patient groups running national ads.
President Donald Trump and FDA officials have pointed to a surge in generic drug approvals, but a data analysis indicates almost half haven’t reached the market.
Patients are often forced into using brand names because drug formularies favor them over cheaper competitors.