Articles tagged with "FDA approval"

Certolizumab Pegol Receives FDA Approval for Plaque Psoriasis

Michele B. Kaufman, PharmD, BCGP | June 18, 2018

On the basis of data from multiple clinical trials, the FDA has approved certolizumab pegol for treating moderate to severe plaque psoriasis…

Ferumoxytol Injection Receives New Indication, & Application for GP2017 Moves Ahead

Michele B. Kaufman, PharmD, BCGP | February 20, 2018

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

Ben Hirschler | October 23, 2017

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

Michele B. Kaufman, PharmD, BCGP | October 2, 2017

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

Gene Emery | September 22, 2017

(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….