PR Newswire

Zydus and Formycon: FYB206 Becomes First Publicly Announced Keytruda® Biosimilar Accepted for Review by USFDA

The US Food and Drug Administration (USFDA) has accepted the Biologics License Application (BLA) for FYB206 for review. To ...
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Cemdisiran Regulatory Submissions Accepted for Review by FDA and EMA for the Treatment of Generalized Myasthenia Gravis (gMG)

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Vertex Announces New Drug Submission for Suzetrigine Has Been Accepted for Review by Health Canada for the Treatment of Moderate-to-Severe Acute Pain in Adults

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GSK's Jemperli (dostarlimab) accepted for review by Health Canada for patients with dMMR/MSI-H locally advanced rectal cancer

Submission supported by AZUR-1 data showing a significant proportion of participants had no detectable signs of cancer one year or more after treatment completion If approved, Jemperli could ...