Biosimilar developers should expect case-by-case evaluations, as the draft offers no hard rules on when CES will be waived. Developers are encouraged to consult the FDA early to understand evidentiary ...

The agency announced new draft guidance to simplify biosimilarity studies and reduce clinical testing that it has deemed ...

The draft guidance, which is touted as a way to reduce the cost and time-associated burden of biosimilar development, has ...

By emphasizing analytical studies instead of routine clinical trials, the FDA signals its intent to reduce the cost (often estimated at $100 million to $300 million) and time (typically 6–9 years) ...

It is fair to say (no matter what else can be said) that the current administration is outcome- rather than process-driven. This general ...

The US Food and Drug Administration (FDA) announced Wednesday that it will relax certain rules for approving low-cost versions of some high-priced medications, in an effort to speed up access to ...

Texas Attorney General Ken Paxton has asked a federal judge to force the makers of Tylenol to stop any advertising that the ...

The U.S. Food and Drug Administration (FDA) has approved two new biosimilars as reference products for Prolia (denosumab) and XGEVA® (denosumab): Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo ...

Health Secretary Robert F. Kennedy Jr.’s latest action takes aim at fluoride, a chemical that is a mainstay of dental care.

The Food and Drug Administration is restricting the use of fluoride supplements used to strengthen children’s teeth.

The warning covers some imported cookware products made from aluminum, brass, and aluminum alloys, known as ...