US FDA advisory committee will weigh in on clinical development plan for SA4Ag, an S. aureus vaccine for prophylactic use, including whether safety and efficacy data from an ongoing, Phase II trial in spinal surgery patients are generalizable to other elective orthopedic surgical populations.
The US FDA seeks advisory committee input on whether a Phase II study of Pfizer Inc.'s investigational Staphylococcus aureus vaccine SA4Ag in spinal surgery patients could support approval for prophylactic use in other elective orthopedic surgical populations, as the sponsor asserts.
On Nov. 7, the Vaccines and Related Biological Products Advisory Committee will discuss the clinical data needed to support an...
Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.
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.
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.
The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
