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A Rundown Of Real-Time Oncology Review Approvals And Pending Applications

 
• By Bridget Silverman and Sue Sutter

Seattle Genetics holds the award for fastest supplemental approval (11 days) and fastest new molecular entity approval (119 days) under the US FDA's RTOR program, according to the Pink Sheet's Performance Tracker.

The US FDA has approved supplements for 17 drugs, as well as four new molecular entities and novel biologics, under the Real-Time Oncology Review pilot since the program launched in February 2018.

The RTOR program has produced exceedingly quick review times in some cases. Seattle Genetics, Inc.’s Adcetris (brentuximab vedotin) holds...

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More from Approvals

EU Pharma Reform: Lawyers Unpack Diverging Visions For Innovation

 
• By Eliza Slawther

There are now three draft versions of the legislative text that will overhaul the framework governing pharmaceuticals in the EU. Lawyers explain how the approaches proposed by the European Commission, European Parliament and Council of the EU differ and highlight implications for industry.

New EU Filings

 
• By Neena Brizmohun

Linerixibat, GSK's treatment for cholestatic pruritus in patients with primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

EMA Nod For First MASH Drug Rezdiffra, Cell Therapy Zemcelpro And 11 Others

 
• By Eliza Slawther

Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.

Lerodalcibep And First Generic Palbociclib Among 10 New EMA Filings

 
• By Neena Brizmohun

Lerodalcibep and palbociclib are among the latest new drugs that the European Medicines Agency has started to review for potential EU marketing authorization.

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