The U.S. health regulator on Friday approved Innoviva's oral antibiotic to treat gonorrhea, a common sexually transmitted ...

The U.S. Food and Drug Administration (FDA) is considering adding the strongest safety warning available to COVID-19 vaccines ...

The U.S. Food and Drug Administration has approved Pfizer's Padcev (enfortumab vedotin-ejfv), a Nectin-4 directed ...

The 2025-2026 COVID-19 vaccine formulation targets the SARS-CoV-2 sublineage LP.8.1, in line with FDA guidance to more closely match circulating strains1 Shipping of the LP.8.1-adapted vaccine will ...

The FDA is investigating a safety signal from Takeda’s rare disease med Adzynma. Otsuka won a first-in-class FDA approval to ...

Johnson & Johnson's Akeega is opening new fronts in prostate cancer treatment with a fresh FDA approval making it the first ...

FDA moves reshaping drug policy include fast-track programs, updated biosimilar guidance, and new rare disease approval pathways.

Shares of several major vaccine makers lost ground Monday following a report U.S. vaccine approval rules could become stricter.

The Food and Drug Administration (FDA) is investigating whether the COVID-19 vaccines were associated with any deaths across ...

The ongoing Phase 3 clinical trial of Pfizer/BioNTech's coronavirus vaccine confirms its protection lasts at least six months after the second dose, the companies said Thursday. The companies can now ...

Pfizer Is Still Struggling to Replace Its COVID Revenue. Here's What We Could See From the Pharmaceutical Giant in 2026. Keep ...