Potential blockbusters and root-cause treatments from Eli Lilly, Merck, Takeda and others could get a regulatory nod this ...

46 new molecular entities cleared the agency’s hurdles last year, 4 fewer than in 2024 ...

In this study, researchers sought to determine the impact of the FDA’s Accelerated Approval pathway among patients with solid tumors.

The US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate ...

A new drug combination shows unexpected synergy against liver fibrosis. A new study reveals that using two drugs together produces a much stronger effect than using either one alone, suggesting a ...

The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs. The ...

The Food and Drug Administration (FDA) recently approved a new generic version of abortion pill mifepristone, a move conservatives are blasting as a “complete betrayal” after Health Secretary Robert F ...

The US Food and Drug Administration’s longtime oncology chief has filed to retire from the agency just weeks after he was chosen to lead the FDA’s drug division, according to four people familiar with ...

Dr. Céline Gounder, an internist, epidemiologist and infectious disease specialist, is a CBS News medical contributor as well as senior fellow and editor-at-large for public health at KFF Health News.

The U.S. Food and Drug Administration (FDA) issued a nationwide recall of thousands of bottles of blood-pressure medication last week after discovering cross-contamination with another drug. Federal ...

The U.S. Food and Drug Administration (FDA) has been rocked by recent changes to several leadership roles while it has grappled with how to handle new vaccine guidance. The agency has changed — five ...

Health system pharmacists and clinicians are monitoring a wave of drug approvals expected throughout 2026, including first-in-class therapies and expanded uses of existing drugs with implications for ...