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Keeping Track: US FDA Clears Two More Biosimilars, First Non-Injectable Glucagon

 
• By Michael Cipriano

The latest drug development news and highlights from our US FDA Performance Tracker.

Keeping Track Feature image

On the heels of Amgen Inc. and Allergan PLC launching the first two oncology biosimilars in the US, the US Food and Drug Administration approved a pair of new biosimilars just days later: Pfizer Inc.'s Ruxience (rituximab-pvvr) and Samsung Bioepis Co. Ltd.'s Hadlima (adalimumab-bwwd).

Eli Lilly & Co

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Blenrep’s Revival Gains Steam: EMA Decision Imminent As Japan Approves New Regimen

 
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New EU Filings

 
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Biomarker Negativity At Issue In Pfizer Bid To Broaden Talzenna CRPC Claim

 
• By Bridget Silverman

The FDA questioned Pfizer’s reliance on a “large, incompletely defined” subgroup of castration-resistant prostate cancer patients without known HRR gene alterations in its review of the proposed expansion of Talzenna’s first-line indication for HRR-mutated CRPC to an all-comers population.

UroGen’s Mitomycin: Are Randomized Trials For Bladder Cancer Necessary?

 
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The Oncologic Drugs Advisory Committee will vote on the risk-benefit of UGN-102 for low-grade, intermediate-risk, non-muscle invasive bladder cancer based on data from a single-arm trial, but the FDA also seeks input on requiring randomized studies for future treatments.

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