Keeping Track: US FDA Acts On 5 Novel Drugs: Approval For Fotivda, Pepaxto, Azstarys; CRLs For Defencath and Oral Paclitaxel

The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker

Keeping Track Feature image

The US Food and Drug Administration doubled the size of the 2021 class of novel cancer therapies with the recent approval of AVEO Pharmaceuticals, Inc.’s Fotivda (tivozanib) and Oncopeptides AB’s Pepaxto (melphalan flufenamide).

More from Approvals

EMA Hits 15-Year Peak With 114 Positive Drug Recommendations In 2024

 

The European Medicines Agency’s chief medical officer, Steffen Thirstrup, said the surge in positive opinions adopted by the agency in 2024 for new marketing approvals signals a post-COVID recovery.

Pink Sheet Podcast: US FDA And Trump’s Reforms, CDER Director Parting Comments, 2024 Approval Trends

Pink Sheet editors consider ex-FDA officials’ advice for the Trump Administration on implementing FDA reforms, comments CDER Director Patrizia Cavazzoni made before her departure from the agency about wanting to release review documents for applications that received complete response letters, and diverging trends between CDER and CBER novel application approvals.

New EU Approvals

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Gohibic (vilobelimab), InflaRx’s treatment for adult patients with SARS-CoV-2-induced acute respiratory distress syndrome.

EMA Pushes For Industry Collaboration On Psychiatric And Psychedelic Drug Innovations

 

The European Medicines Agency wants to work with other regulators as well as industry, scientists and patients to “find solutions for the most pertinent problems in psychedelic research” and improve treatment options for psychiatric disorders more broadly, says the agency.

More from Product Reviews