EMA
The EMA has voted in favor of EU approval for five new products, including treatments for a rare, life‑threatening genetic disorder and for non‑cirrhotic MASH, and has also recommended reversing its earlier rejection of an orphan drug for chronic graft‑versus‑host disease.
The European Medicines Agency is set to adopt opinions on whether marketing approval should be granted to five new products, including therapies for a serious liver disease and an ultra‑rare genetic mitochondrial disorder.
The European Medicines Agency has not “always fared favorably” compared to other countries such as the US when it comes to drug approval timelines, but the reform of the EU pharma legislation is a key opportunity to “think out of the box,” says the agency’s head of therapeutics areas.
Scientific advances in pharmacogenomics have prompted the European Medicines Agency to propose revisions to its existing guideline to ensure its continued relevance and applicability.
US FDA
Richard Pazdur plans to remain involved in drug development after leaving the FDA.
As the FDA sees another quarter with a net loss of employees in CDER and CBER, Pink Sheet editors discuss the potential impact and where it could manifest.
CDER and CBER added more people in the first quarter of FY 2026 than the previous two quarters combined, but departures still outnumbered the additions.
Recommendations to mitigate attrition among clinical research and drug manufacturing investigators at the FDA have not been implemented, and a Strategic Workforce Plan aimed at addressing recruiting, retention and training challenges has been shelved, the Government Accountability Office said.