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Keeping Track Of Approvals: Cancer, Cancer, And A Two-Week Cancer Review

 
• By Michael Cipriano, Bridget Silverman, and Nielsen Hobbs

The latest drug development news and highlights from our US FDA Performance Tracker. 

Keeping Track Feature image

We'll skip an introduction this week to save room for dessert, but suffice to say that several sponsors have something to be thankful for after US FDA approvals.

FDA set a new speed record for supplemental applications considered under the agency’s Real-Time Oncology Review (RTOR) with the Nov....

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More from Approvals

New EU Filings

 
• By Neena Brizmohun

Insulin efsitora alfa, Eli Lilly’s once-weekly, subcutaneous treatment for type 2 diabetes, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Japan Roundup: Approvals Recommended For Ibtrozi, Voranigo And Ycanth

 
• By Lisa Takagi

Along with multiple new therapeutics for NSCLC, Astellas's Izervay and several products licensed from US companies receive approval recommendations in Japan.

First-Of-A-Kind Nasal Spray For Pain In Children Among 13 New EU Filings

 
• By Neena Brizmohun

Cessatech and Proveca’s investigational, sufentanil/ketamine fixed-dose combination analgesic nasal spray is among the latest drugs that the European Medicines Agency has started to review for potential pan-EU marketing authorization.

US FDA Upheaval Forces User Fee Talks To Begin Later Than Usual

 
• By Derrick Gingery

The fall start of PDUFA and GDUFA negotiations could impact the agreement review process and other parts of the schedule intended to ensure it reaches Congress on time.

More from Product Reviews

Japan Roundup: Approvals Recommended For Ibtrozi, Voranigo And Ycanth

 
• By Lisa Takagi

Along with multiple new therapeutics for NSCLC, Astellas's Izervay and several products licensed from US companies receive approval recommendations in Japan.

US FDA Compounding Advisory Panel Hit Hardest By Recent Purges

 
• By Sarah Karlin-Smith

A Pink Sheet review found 10 FDA advisory panel members recently pulled off committees despite having time left in their appointed terms.

First-Of-A-Kind Nasal Spray For Pain In Children Among 13 New EU Filings

 
• By Neena Brizmohun

Cessatech and Proveca’s investigational, sufentanil/ketamine fixed-dose combination analgesic nasal spray is among the latest drugs that the European Medicines Agency has started to review for potential pan-EU marketing authorization.