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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...

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More from Approvals

New EU Filings

 
• By Neena Brizmohun

Arimoclomol, Zevra Therapeutics's treatment for Niemann-Pick disease Type C, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Sanofi Secures EU Fast-Track Status For ‘Game-Changing’ Sleeping Sickness Drug

 
• By Neena Brizmohun

If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.

EU 2025 Novel Drug Approvals See Conditional Authorizations Outpacing Previous Years

 
• By Neena Brizmohun

The six EU conditional marketing authorizations granted in the first half of 2025 alone equal the full count for 2024 and come close to the annual totals for the previous two years. Meanwhile, 1H 2025 saw a 30% rise in new active substance approvals compared to the same period last year.

Expedited Reviews For China-Originated Drugs Shift Back Home

 
• By Xu Hu

The proportion of China-originated drugs granted expedited reviews in China doubled in the first half of this year, Pharmaprojects data show, surpassing those receiving similar treatment in the US and likely driven by multiple factors.

More from Product Reviews

NDA User Fees Will Grow 8.6% Next Year As FDA Projects More Applications But Fewer Sponsor Meetings

 
• By Nielsen Hobbs and Derrick Gingery

The ups – and some downs – of the US FDA’s prescription, biosimilar, and generic user fees for FY 2026 are tabulated by the Pink Sheet.

EU 2025 Novel Drug Approvals See Conditional Authorizations Outpacing Previous Years

 
• By Neena Brizmohun

The six EU conditional marketing authorizations granted in the first half of 2025 alone equal the full count for 2024 and come close to the annual totals for the previous two years. Meanwhile, 1H 2025 saw a 30% rise in new active substance approvals compared to the same period last year.

New EU Drug Safety Rules Scrap Signal Detection Pilot, Boost Audit & Subcontracting Controls

 
• By Vibha Sharma

The European Commission has adopted new rules to cut red tape in pharmacovigilance, tighten oversight of outsourced drug safety activities, and ensure a balanced approach to signal detection, boosting both efficiency and patient safety.