CDER’s 2024 Report: A year of breakthrough therapies and record approvals – The Babak Lab
The Babak Lab shared a post on LinkedIn:
“Clinical Mondays: CDER’s 2024 Report
A Year of Breakthrough Therapies and Record Approvals!
The FDA’s Center for Drug Evaluation and Research (CDER) had a landmark year in 2024, bringing safe, effective, and innovative treatments to patients faster than ever.
Their annually released New Drug Therapy Approvals report highlights:
– 50 novel drug approvals, including 26 for rare diseases – some with no prior treatment options, like Neimann-Pick disease type C and WHIM syndrome.
– Three new antibiotics and multiple cancer therapies, expanding hope for patients with serious conditions.
– A record 18 biosimilars approved – the most in a single year – including 9 interchangeable biosimilars, increasing affordability and access.
– 66% of novel drugs approved through expedited programs, ensuring faster access to life-saving therapies.
– 68% of new drugs were approved in the U.S. before any other country, reinforcing America’s leadership in medical innovation.
Read the full report here.”
Maria (Masha) Babak, Head of The Babak Lab and an Assistant Professor at the City University of Hong Kong, shared this post, adding:
“Exciting progress from the FDA’s 2024 report highlights breakthrough treatments for rare diseases and a record number of biosimilar approvals, accelerating patient access to innovative therapies.
Have a read!”
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