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Keeping Track: Review Underway For Linhaliq, New Uses Of Lenvima, Cimzia; New Cycle Starts For Lutathera

 
• By Bridget Silverman

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

Keeping Track Feature image

July ended for FDA with a burst of approvals and submissions, but the activity largely surrounded already-approved molecules with new formulations, indications, and regimens. Here's your news in brief:

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More from Approvals

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Tivdak, Pfizer/Genmab’s treatment for previously treated recurrent or metastatic cervical cancer.

Leqembi Launch Set For Germany & Austria After Winning EU Approval At Last

 
• By Neena Brizmohun

Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.

African Medicines Agency Set To Launch With New Leader In April

 
• By Anabel Costa-Ferreira

The African Medicines Agency is to appoint a director general and become operational at the end of this month.

More from Product Reviews

Chikungunya At US CDC: Bavarian Nordic’s Vimkunya Recommended, Valneva’s Ixchiq Adjusted

 
• By Bridget Silverman

Bavarian Nordic's Vimkunya added the US CDC immunization committee's recommendation to its FDA approval, while Valneva's Ixchiq faces a precaution for use in people aged 65 and older.

US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems

 
• By Sarah Karlin-Smith

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.

US FDA User Fee Collection Safe In Preliminary Trump 2026 Budget Plan

 
• By Cathy Kelly

The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.