Records show that a top U.S. regulator rejected the recommendations of agency experts and limited the use of Covid vaccines.

The FDA didn’t routinely test the medications for quality problems or use its vast repository of drug-related complaints to proactively track whether they were harming the people who relied on them.

Bio-Thera Solutions, Ltd, a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets and Hikma Pharmaceuticals PLC, along with its wholly owned subsidiary ...

FDA biosimilar approvals reached a record 19 in 2024, with projections indicating that 2025 could surpass this milestone trend.

Fresenius Kabi, an operating company of Fresenius, and Formycon AG, announced today that the U.S. Food and Drug Administration (FDA) designated Otulfi® (ustekinumab-aauz) as an interchangeable ...

2024 saw the highest number of biosimilars approved by the US Food and Drug Administration (FDA) in a calendar year, with this year set to break this record again, analysis suggests. The FDA ...

The Food and Drug Administration (FDA) has designated Yuflyma ® (adalimumab-aaty) an interchangeable biosimilar to Humira ® (adalimumab). Yuflyma, a tumor necrosis factor (TNF) blocker, was ...

Enbrel generated $3.3 billion in U.S. revenue in 2024 alone. Erelzi, FDA-approved in 2016, remains unavailable in the U.S. due to contested Enbrel patents. Market-moving news hits Benzinga Pro ...

The U.S. Food and Drug Administration has approved Jobevne (bevacizumab-nwgd), a biosimilar to Avastin (bevacizumab) for intravenous use in cancer types including colorectal cancer, non-small cell ...

The Food and Drug Administration (FDA) has approved Merilog (insulin-aspart-szjj), a biosimilar to Novolog (insulin aspart), to improve glycemic control in adults and pediatric patients with ...