More recently, the FDA posted two two letters: one backdated for September 9, regarding GSK’s HIV medication Apretude and one ...

FDA's new guidance clarifies promotional practices for biosimilars, ensuring accurate marketing and preventing misleading ...

" It sounds wholesome, right? Pure. Like something your grandmother might have used in her kitchen. The clean label movement has exploded in recent years, with half of industry professionals ...

The drugs have soared in popularity, with some men taking them for unapproved uses like anti-aging or increasing muscle mass.

Promo materials should also refrain from positioning one approved biosimilar as better than another for the same reference ...

Groups representing major companies, including Kraft Heinz and Coca-Cola, argue the law misleads consumers and violates the ...

Capricor shows positive HOPE-3 results with endpoints met, regulatory uncertainty, and a strong cash runway into 2026. Find ...

Simplifying nutrition information can empower consumers to make healthier, more informed dietary choices and reduce their risk of cardiovascular disease (CVD), according to guidance issued by the ...

Eli Lilly and Co. (LLY) announced that the U.S. Food and Drug Administration (FDA) has approved Jaypirca (pirtobrutinib, 100 mg and 50 mg tablets) for the treatment of ...

Approval is based on results from the BRUIN CLL-321 trial, the only randomized Phase 3 study in CLL/SLL in which all patients were previously treated with ...

Vinay Prasad, the head of the US FDA's Center for Biologics Evaluations and Research which oversees vaccines, said that future vaccine approvals will face stricter standards in light of the deaths of ...

Facing backlash over recent policy wording, the Coast Guard moved Thursday to make one thing clear: "hate symbols" such as swastikas and nooses remain forbidden in the service. The Coast Guard ...