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

Another BCMA-targeted agent has arrived for the treatment of multiple myeloma. | After a delay, Regeneron’s BCMA-directed ...

Traditional and new laboratory tools along with advances in AI are outlining a new paradigm in human disease modeling.

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.

Pfizer jumps into cancer-treatment race with a $6 billion licensing deal with a China-based company, six months after Merck’s move for a lot less money.

Peer Reviewed: Isotopically Labeled Analogues for Drug Quantitation Issues to address when isotopically labeled analogues of analytes are used as internal standards. Ray H. Liu , D.-L. Lin , Wei-Tung ...

From 2020 to 2024, universities contributed patents underpinning 50% of FDA-approved drugs. 87% of those academic breakthroughs came from American institutions.

Keytruda posted global sales of $29.5 billion in 2024, making it a major target for biosimilar development. Alvotech and Dr. Reddy's will share development, manufacturing, and commercialization ...

All were going blind — and all happened to be taking Elmiron, a drug for a bladder condition called interstitial cystitis. In 2018, Jain and his colleagues published their findings about this new ...

The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application ...