FDA Approves First & Only Tx for IgG4-RD – Uplizna
The FDA recently approved a new indication for an infused therapy, Uplizna (inebilizumab-cdon) from Amgen. While the therapy was originally approved in 2020, this approval
July 2, 2025
The FDA recently approved a new indication for an infused therapy, Uplizna (inebilizumab-cdon) from Amgen. While the therapy was originally approved in 2020, this approval
Earlier this week, we delved into the topic of Accelerated Approval Pathways and the critical role played by surrogate endpoints. Today, let’s delve even deeper
Quiz me this……….What is a surrogate endpoint, and what the heck do they have to do with a drug obtaining Accelerated Approval? People working in
Global Pharma industry has been buzzing about the looming tariffs from the US being applied for everything from Hello Kitty chotchkie to, ‘say it ain’t
A recent Executive Order directing HHS to develop price targets for imported drugs has really stirred up the hornet’s nest. It is common knowledge that
The FDA recently approved a new treatment, Qfitlia (fitusiran) from Sanofi, for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult
Oncology products continue to be the top products driving the pharma marketplace. They are among the most expensive and complex due to the numerous iterations
The FDA recently approved a therapy originally approved in 1983, Vykat XR (diazoxide choline) from Soleno Therapeutics, based on a breakthrough indication for the treatment
Announcements for newly approved specialty drugs often state that the product will be available through specialty pharmacy in limited distribution. However, the early press releases
The past year has brought rough financial seas to Walgreens. As recently as this January we reported on Walgreens plans to possibly go private after closing
