The European Union's medicines regulator on Friday granted a conditional authorisation for Madrigal Pharmaceuticals' drug for ...

A federal judge has rejected a bid by compounding pharmacies to allow them to continue making copies of Novo Nordisk's ...

Biotechnology and pharmaceutical industry professionals turn to digital microscopy for consistent and efficient electronic ...

The warning letters deal with a range of violations involving items from personal hygienic products to mismarketed analgesics.

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But experts say the FDA should have no illusions regarding the unreliability of such surrogate outcomes, especially since these outcomes fail to take into account the harms a drug may cause, such as ...

Ordinarily, the holder of an approved new drug application (NDA) or an approved abbreviated new drug application (ANDA) must ...

The "Non-Conformance and Corrective Action for Medical Device Manufacturers Training Course" training has been added to ResearchAndMarkets.com's offering.

The Food and Drug Administration approved the new vaccine for use in all adults 65 and older, and for people age 12 to 64 who have a least one health condition that puts them at increased risk ...

This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the ...