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Oncology Approvals At US FDA Could Pick Up Over Summer

 
• By Bridget Silverman

Only two novel oncologics have cleared the FDA’s approval bar in 2019, but the Pink Sheet’s user fee tracker shows at least eight candidates under review, along with seven significant new indications and formulations.

Pending adn Completed tasks

As the pharma world turns its eyes to the American Society of Clinical Oncology meeting, the US Food and Drug Administration has at least eight novel oncology agents under review, according to data from the Pink Sheet’s US FDA Performance Tracker.

In terms of novel approvals, oncology has had a slow start in 2019. The approval of Novartis AG’s Piqray (alpelisib) on 24 May for PIK3CA-mutated breast cancer patients brings the number of novel oncologics approved to two; the first, Johnson & Johnson’s Balversa (erdafitinib) cleared the FDA on 12 April for previously treated FGFR-mutated metastatic urothelial carcinoma patients

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Ryoncil Chronology: Three Review Cycles, Two CRLs, One Dispute Resolution Request

 
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FDA Adcomms Are Back: Four Cancer Drugs, COVID-19 Vaccine Formulations To Get Reviews

 
• By Sue Sutter and Bridget Silverman

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Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
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