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Pfizer’s Comirnaty: Emerging Myocarditis Signal Drew Flurry Of Attention During Compressed BLA Review

 
• By Sue Sutter

Multiple offices within CBER worked to get a handle on the myocarditis issue in the midst of a three-month review of the COVID vaccine, with US FDA staff undertaking a quantitative benefit-risk assessment and negotiating with Pfizer on postmarket safety studies.

Drug Review Profile: Comirnaty
US FDA's Review of Pfizer/BioNTech SE’s COVID-19 vaccine became unexpectedly more complicated mid-cycle with the emergence the myocarditis side effect.

The occurrence of myocarditis cases among older male adolescents and young men who received Pfizer Inc./BioNTech SE’s COVID-19 vaccine drew extensive focus from the US Food and Drug Administration late in the Comirnaty biologics license application’s speedy review.

Publicly released FDA documents reflect a flurry of activity within the Center for Biologics Evaluation and Research on the myocarditis signal in July and August, with review activities that included...

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Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened

 
• By Sarah Karlin-Smith

The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.

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

 
• By Bridget Silverman

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

 
• By Sue Sutter

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