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Keeping Track: Neurology And Breakthroughs Stay In Spotlight As US FDA Approves Radicava, Imfinzi; TaiMed Submits Ibalizumab

 
• By Bridget Silverman

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

Keeping Track Feature image

FDA slowed – slightly – its recent torrid pace of novel agent approvals, clearing two more new products to bring the 2017 count of new molecular entities and novel therapeutic biologics to 20.

In all of 2016, FDA's Center for Drug Evaluation and Research cleared 22 novel agents, so it should be safe...

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More from Approvals

US FDA’s Second Half 2025 User Fee Goals Swing Toward Respiratory Disease

 
• By Bridget Silverman

The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year

Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 
• By Bridget Silverman

US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.

EMA’s PRIME Scheme Explored: Growing Designations - But Are Accelerated Assessments Slipping?

 
• By Neena Brizmohun

While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.

What Pharma Needs To Know About Vietnam’s Drug Registration Reforms

 
• By Neena Brizmohun

Newly introduced rules for streamlining drug registration in Vietnam are said to present both opportunities and challenges for stakeholders.

More from Product Reviews

US Return Of GSK’s Blenrep Threatened By Ocular Toxicity, Dosage Optimization Questions

 
• By Sue Sutter

The FDA's Oncologic Drugs Advisory Committee will consider whether appropriate dosages of belantamab mafodotin have been identified for two second-line, multiple myeloma indications. Ocular toxicities and large number of dose modifications in trials raised FDA concerns about benefit-risk.

Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 
• By Bridget Silverman

US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.

US FDA To Advisory Committee Industry Reps: Don’t Talk Too Much

 
• By Sue Sutter

Nonvoting industry representative’s presence at Pediatric Advisory Committee meeting was required by statute, the agency said, a de facto acknowledgement that an April directive precluding industry reps from sitting on advisory committees has had little practical effect.