News

GSK seeks FDA nod for expanded use of RSV vaccine in adults
British drugmaker GSK said on Monday it had submitted an application to the U.S. Food and Drug Administration to extend the ...
FDA issues highest risk warning after mushrooms recalled nationwide
The Class I recall status indicates that the product poses a risk of causing serious health consequences or death if consumed ...
FDA Commissioner: 100 Days of Change—Modernizing the FDA for a Healthier America | Opinion
The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and ...
US FDA declines to approve Ultragenyx's gene therapy for rare genetic disorder
The U.S. Food and Drug Administration has declined to approve Ultragenyx Pharmaceutical's experimental gene therapy to treat ...
San Francisco-based company gets FDA approval to produce plant-based salmon
One San Francisco-based company aims to find a sustainable alternative by creating plant-based salmon, and with its recent ...
FDA funding clash looms between Senate, House
Despite the Trump administration’s efforts to shrink the FDA, Senate appropriators unanimously advanced a funding bill ...
Capricor shares sink as US FDA declines to approve cell therapy
The U.S. Food and Drug Administration has declined to approve Capricor Therapeutics' cell therapy for a heart condition, the ...
Weaver Nut Company chocolate recall under FDA's highest risk level
The FDA recalled some chocolate products by the Weaver Nut Company chocolate, warning about possible serious to ...
Senate panel clears FDA appropriations
Presented by Express Scripts Pharmacy Benefit Services{beacon} Health Care Health Care   The Big Story Senate panel clears ...
FDA commissioner backs MAHA push to improve food safety
FDA Commissioner Dr. Marty Makary joins ‘Fox & Friends’ co-host Steve Doocy for a morning walk to discuss the agency’s focus ...
FDA Commissioner: ‘We want to focus on food’
“We want to focus on food. People forget that the ‘F’ in FDA stands for food,” Makary said. Makary noted that the processed ...
FDA to consider drug affordability when granting new vouchers to speed up approvals, Makary says
It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually ...