The 5th U.S. Circuit Court of Appeals affirmed Aug. 27 that the FDA acted lawfully when it declared Eli Lilly's tirzepatide shortage resolved, according ...

Foreign and domestic medical device facilities, as well as the companies that source from them, should ensure they renew their registrations on time. The current renewal period opens Oct. 1 and will ...

Updated COVID vaccines are necessary, just as flu vaccines are updated because immunity wanes with time, even among those ...

This article explores the current state of design controls for software as a medical devices (SaMDs), focusing on the FDA’s ...

Alvotech is targeting a potentially significant fourth quarter of 2026, with U.S. regulatory decisions anticipated for three biosimilar programs following resubmissions to the FDA and the closure of a ...

HONOLULU (KHON2) -- New proposed rules from the Hawaiʻi Department of Land and Natural Resources are sparking debate over how the state should manage cats and other animals on public lands. DLNR is ...

Aug 19 (Reuters) - A federal appeals court has ruled that the U.S. Food and Drug Administration overstepped its authority by trying to require that cigarette packages and advertisements contain 11 ...

The Securities and Exchange Commission (SEC) delivered a bit of a surprise today by proposing new rules for crypto offerings. Regulation Crypto Assets would clarify how securities laws apply to ...

The Securities and Exchange Commission (SEC) on Tuesday proposed a set of rules called Regulation Crypto Assets that aims to let cryptocurrency companies raise capital without facing the traditional ...

This voice experience is generated by AI. Learn more. This voice experience is generated by AI. Learn more. The FDA has proposed a significant rule change, ending a practice where food manufacturers ...