Tag Archives: Administration

U.S. Food and Drug Administration Approves New Formulation of Epclusa, Expanding Pediatric Indication to Treat Children Ages 3 and Older With Chronic Hepatitis C

FOSTER CITY, Calif.–(BUSINESS WIRE)–Jun. 10, 2021– Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the U.S. Food and Drug Administration (FDA) has approved an expansion of the pediatric indication of Epclusa (sofosbuvir/velpatasvir) for the treatment of chronic hepatitis C virus (HCV) to now include children as young as 3 years of age, regardless of HCV… Read More »

Pharma erupts as Biden administration backs waiver of vaccine patent rights

The Biden administration’s call to waive patent rights for coronavirus vaccines sparked vociferous opposition from drugmakers and pharma industry groups, which quickly claimed the move will discourage future drug research and do little to increase supply.  Activists, who have pressured the administration for months on the issue, argue a waiver is needed to begin removing… Read More »

The Trump Administration Shut a Vaccine Safety Office Last Year. What’s the Plan Now?

As the first coronavirus vaccines arrive in the coming year, government researchers will face a monumental challenge: monitoring the health of hundreds of millions of Americans to ensure the vaccines don’t cause harm. Purely by chance, thousands of vaccinated people will have heart attacks, strokes and other illnesses shortly after the injections. Sorting out whether… Read More »

Trump Administration Says Some Coronavirus Tests Can Bypass F.D.A. Scrutiny

The Trump administration this week ordered the Food and Drug Administration to allow the use of a certain class of laboratory tests, including some for the coronavirus, without first confirming that they work. For months some F.D.A. officials have worried that the pandemic would provide an opening for clinics, academic institutions and commercial labs to… Read More »