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Europe's CHMP reverses endorsement of Amgen's Tavneos as FDA hearing looms
As Amgen prepares to defend Tavneos’ market approval in the U.S., the company has received a bad omen overseas, with regulators recommending that the ANCA-associated vasculitis drug lose its author | As Amgen prepares to defend Tavneos’ market approval in the U.S., the company has received a bad omen overseas, with regulators recommending that the ANCA-associated vasculitis drug lose its authorization in the European Union after a new review led to the conclusion that its benefits are “no longer proven to outweigh its risks.”
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fiercepharma.com
Amid safety concerns, ADC Therapeutics plots 17% staff cuts to push resources behind Zynlonta
In the wake of a recent safety scare in a confirmatory trial of its antibody-drug conjugate Zynlonta, ADC Therapeutics is tightening its belt in an effort to get the most out of…
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FDA shines harsh light on Pinnacle after finding fault with photodynamic therapy videos
The FDA has accused Pinnacle Biologics of creating videos that make it hard for healthcare professionals to “adequately process and comprehend the full indications” for a cancer…
