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Amgen's T-Vec to Receive FDA Decision Today
The vaccine, approved in Europe last week, is now awaiting approval in the United States.
Imlygic, or talimogene laherparepvec, a genetically modified herpes simplex type 1 virus developed by Amgen to be injected directly into tumors, where it replicates and forces tumor cell rupture, is waiting for FDA's decision. The NDA for this virus-based treatment has been submitted for melanoma.
An advisory panel for the FDA reviewed data from the phase 3 OPTiM trial and voted 22-1 in favor of approval back in April 2015. Now the FDA has to consider this panel's advice before it's decision later today.
Meanwhile, the European Medical Agency approved T-Vec for use in patients with unresectable melanoma that has not metastatized just last week.
Read more here.
Elevated Inflammatory Marker Levels Associated With Increased Overactive Bladder Risk
April 15th 2025Systemic immune inflammation index, neutrophil-to-lymphocyte ratio, and systemic inflammation response index levels may offer a noninvasive method to identify individuals at increased risk of developing overactive bladder.
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