Keeping Track: Turalio, Nubeqa And Accrufer Mark Trio Of Novel Drug Approvals
The latest drug development news and highlights from our US FDA Performance Tracker.
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ASCO In Brief: US FDA Looks At Safety Outcomes By Performance Status, Metastasis-Free Survival In Elderly Men
Exploratory analysis suggests cancer patients with poorer baseline status can be enrolled in clinical trials without endangering registration prospects for the drug. Older prostate cancer patients derived a similar benefit to younger patients in metastasis-free survival with androgen-receptor inhibitors, FDA researchers found in an exploratory subgroup analysis of three registrational trials.
EU Approvals: Takeda advances its targeted ALK-positive NSCLC tyrosine kinase inhibitor into early lines of therapy, while Bayer and Finland’s Orion gain clearance for their androgen receptor inhibitor for prostate cancer.
Keeping Track Of User Fee Decisions And Filings: Adakveo, Brukinsa And Fetroja Mark Massive Week Of Novel Approvals
The latest news on US FDA user fee decisions and submissions to the agency.