The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...

Accelerated approval of semaglutide 7.2 mg establishes a higher-dose, once-weekly GLP-1 RA option for long-term weight ...

The U.S. Food and Drug Administration’s (FDA) approval of the first-ever disease-slowing therapy for Alzheimer’s has given hope to millions of Americans, their families, and caregivers who are all ...

Incentives to bring vaccines to market are shrinking. Drugmakers are scaling back research investments and cutting jobs.

The FDA’s Commissioner’s National Priority Voucher program, unveiled in June 2025, is “shrouded in secrecy,” Democratic ...

President Biden is yet again facing backlash over the FDA’s booster approval process, which recommended boosters for children this week without convening a panel of advisors to weigh in on the matter.

The Food and Drug Administration has announced some major changes to the review process for drug developers in the United States. It could cut down the time from 10 to 12 months for a review to just ...

As FDA itself observes, “devices of a new type that FDA has not previously classified … are ‘automatically’ or ‘statutorily’ classified into class III…, regardless of the level of risk they pose.” To ...

Peter Marks, director of Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research noted that “vaccination remains critical to public health and continued protection against ...