Apalutamide, the first drug approved to treat non-metastatic castration-resistant prostate cancer, will also be the first NDA to have clinical summary report information made public under an FDA pilot program to increase transparency.
The swift US approval of Johnson & Johnson subsidiary Janssen Pharmaceuticals Inc.'s Erleada (apalutamide) for treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) suggests that FDA had few concerns with the pivotal trial's novel primary endpoint.
The oral androgen receptor inhibitor was approved on Feb. 14, almost two months before the new drug application's (NDA) April...
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.
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.
Newly introduced rules for streamlining drug registration in Vietnam are said to present both opportunities and challenges for stakeholders.
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.
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.
The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
The Pediatric Advisory Committee supported routine safety monitoring for three vaccines and 21 drugs, but the panel’s consumer representative said adverse event reporting needs improvement and FDA literature reviews should include lawsuits as well as social media.
