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The FDA is busy accepting drug applications, granting specialty designations and approving drugs for market. Here’s a look at this week’s FDA activity.
The FDA has accepted the sNDA for AstraZeneca and Merck’s Lynparza and the sBLA for Genentech (Roche)'s for Polivy in diffuse large B-cell lymphoma.
Merck and Orna will explore various therapeutic and vaccine programs in a collaboration worth a potential $3.5 billion.
As the biotech world awaits the announcement of Merck’s anticipated buyout of Seagen, an arbitrator came down on the side of Daiichi Sankyo in a patent battle against the Seattle-based biotech.
Daiichi Sankyo and AstraZeneca report another first-in-class approval for Enhertu, Bayer snags an sNDA in metastatic hormone-sensitive prostate cancer and Merck faces contamination challenges with Januvia.
The FDA will still allow continued distribution of sitagliptin containing NTTP with an acceptable intake limit of 37 ng per day and up to 246.7 ng per day.
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