Monday, May 12, 2025

FiercePharma: "FDA misses another approval decision target date, this time for GSK's Nucala in COPD"

Via FiercePharma, this news: 

In the wake of mass restructuring efforts across the Department of Health and Human Services (HHS), the FDA has missed yet another approval decision target date.

GSK had expected to secure an FDA nod for its IL-5 antibody Nucala in chronic obstructive pulmonary disease (COPD) on Wednesday, but the May 7 deadline has come and gone without a decision from the U.S. regulator.

“Based on our latest discussions with the FDA, we continue to expect approval,” a GSK spokesperson said in an email.

“The FDA is actively reviewing our submission for Nucala in COPD and we are working closely with them to help bring this important treatment option to patients as quickly as possible,” the spokesperson said, caveating that the company does “not comment on ongoing discussions with regulatory authorities.”

Between the president's new executive order and this news, it very much feels like the Executive Branch is threatening pharma revenue streams directly. I can't imagine this will do anything good for hiring, especially in terms of entry-level R&D positions.  

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looks like Blogger doesn't work with anonymous comments from Chrome browsers at the moment - works in Microsoft Edge, or from Chrome with a Blogger account - sorry! CJ 3/21/20