The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative ...

The agency announced moves to cut regulatory obstacles for the makers of biosimilar drugs, which are akin to generics and may ...

The Trump administration is proposing changes to Food and Drug Administration guidelines that would make it less expensive ...

The US Food and Drug Administration will take steps to streamline the process to develop generic versions of complex ...

Monday after the biotechnology company disclosed disappointing drug-trial data, which could lengthen the timeline of the ...

The United States has said it will speed up approval for some generic drugs. The development comes weeks after it was ...

Here in the USA, we have lived with the confidence that the medications sold over the counter, by prescription or ...

The U.S. Food and Drug Administration announced it will relax certain rules for approving low-cost versions of some ...

Developers of biosimilars, medicines that are near-identical copies of biologic drugs, will no longer be required to conduct clinical trials to prove effectiveness.

So far, the USFDA has approved 76 biosimilars but the market share of these remains below 20% with only 10% of the biologics ...

Biologic medications, while accounting for only 5% of U.S. prescriptions, represent 51% of total drug spending in 2024. Despite FDA-approved biosimilars being as safe and effective as their branded ...

The FDA’s new draft guidance aims to make the approval process faster and less burdensome by limiting the need for ...