Incyte
NEWS
FDA approved Incyte’s Opzelura (ruxolitinib) cream for atopic dermatitis (AD) for the short-term and non-continuous chronic treatment of mild to moderate AD.
From time to time, the U.S. FDA requests additional data from companies who have submitted an application for a new drug or biologic. What’s a bit unusual is every single PDUFA date this week had that happen.
It was a busy week for clinical trial announcements. Take a look.
Eli Lilly and Company is in the news with positive Olumiant data in COVID-19, a drop in COVID-19 product sales for the quarter and a protest of one of their ads. Here’s a look.
The FDA’s ODAC met to discuss retifanlimab and voted 13-4 that a regulatory decision for the drug for this indication should be deferred until more data was available.
The U.S. Food and Drug Administration (FDA) had several PDUFA dates on their calendar for the last week of July, but in two cases, there were problems with the submissions ahead of time. Here’s a look.
The Oncologic Drugs Advisory Committee (ODAC), as part of the U.S. Food and Drug Administration (FDA), has voted 13-to-4 against supporting the accelerated approval of Incyte’s PD-1 inhibitor for squamous cell carcinoma.
Incyte had a particularly big week scheduled with the U.S. FDA, which included two PDUFA dates and an advisory committee meeting. In addition, Ascendis had a target action date.
It was another busy week for clinical trial announcement. Here’s a look.
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