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Results For "US-Food-and-Drug-Administration"

134 News Found

Roche withdraws the US accelerated approval for Tecentriq
Drug Approval | August 28, 2021

Roche withdraws the US accelerated approval for Tecentriq

Roche is notifying healthcare professionals and patients in the US about this withdrawal. Patients being treated with Tecentriq for PD-L1-positive mTNBC should discuss their care with their healthcare provider


SAB Biotherapeutics nonclinical data indicates SAB-185 neutralizes Delta and Lambda SARS-CoV-2 Variants
Drug Approval | August 12, 2021

SAB Biotherapeutics nonclinical data indicates SAB-185 neutralizes Delta and Lambda SARS-CoV-2 Variants

SAB-185 is currently being evaluated in NIH-sponsored Phase 2/3 adaptive trial


GSK files application for MMR vaccine in the US
News | August 11, 2021

GSK files application for MMR vaccine in the US

If approved it will bring a second source of MMR vaccine to the US market


NATCO receives approval for Ibrutinib tablets from ANDA
News | April 11, 2021

NATCO receives approval for Ibrutinib tablets from ANDA

The approval is for Ibrutinib tablets 560 mg, 420 mg, 280 mg and 140 mg strengths