The FDA recently expanded the indications for ferumoxytol injections to include the treatment of adults with iron-deficiency anemia…
GSK Wins U.S. Shingles Vaccine Approval, U.K. Nod for Gene Therapy
LONDON (Reuters)—GlaxoSmithKline has won U.S. approval for a new and improved shingles vaccine, the second of three key products for which the British drugmaker expects approval this year. It also secured a recommendation from U.K. cost authorities for a $700,000 gene therapy for so-called “bubble boy” disease—a step forward for the field of fixing faulty…
Efficacy Studied Following Accelerated Drug Approvals
In recent years, the number of drugs to receive accelerated FDA approval has increased. A new study examined whether these drugs have demonstrated efficacy in post-approval trials…
Many Drug Companies Fail to Conduct Timely Safety Checks on Medicines after FDA Approval
(Reuters Health)—In the rush to approve new medicines, the U.S. Food and Drug Administration often requires drug companies to study possible side effects and alternative doses for medicines once they hit the broader market. A September 20 online analysis in the New England Journal of Medicine concludes that, in many cases, that’s not being done….