In April 2025, the FDA announced plans to shift biomedical research for monoclonal antibodies and other medications away from animal testing toward new approaches. One year later, much speculation ...

The FDA has faced an extraordinary convergence of political, scientific, legal, and operational pressures over the last year.

The FDA's draft guidance could streamline biosimilar approval by reducing the need for comparative efficacy studies, emphasizing analytical assessments instead. This approach may lower development ...

Big pharmaceutical companies are boosting their production capacity of branded medications with billions of dollars in new U.S. manufacturing plant construction, but generic drug production still ...

Treatments for Alzheimer disease agitation, focal segmental glomerulosclerosis, hematological malignancies, HIV-1, and obesity are under review.

WASHINGTON (AP) — The head of the Food and Drug Administration’s drug center abruptly resigned Sunday after federal officials began reviewing “serious concerns about his personal conduct,” according ...

SHELTON, CONNECTICUT / ACCESS Newswire / February 10, 2026 / NanoViricides, Inc., a publicly traded company (NYSE ...

In the Senate, every Republican, seven Democrats and one independent who caucuses with Democrats voted for the bill. In the House, all but two Republicans voted in favor alongside six Democrats who ...