15 July 2025
15 July 2025
The WHO’s Director-General described the policy guidelines for Gilead’s twice-yearly drug as the “next best thing” in the absence of a vaccine.
LEO has plans for Spevigo beyond generalised pustular psoriasis as it looks to boost its dermatological pipeline.
Alyftrek is approved for individuals aged six years and older with at least one F508del mutation.
The company plans to utilise the funds to extend its research into immune disorders.
The decision follows the initial approval granted in September 2023, which covered patients aged five years and above.
GSK looks to compete with Pfizer and Moderna in the 18-49 age group of the RSV vaccine market in the US.
The FDA's request stems from observations made during recent inspections of Ultragenyx's manufacturing facilities.
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