Get daily updates on important FDA approval, PDUFA dates, and FDA Advisory Committee Meetings with RTTNews FDA Calendar & Upcoming Approvals.
Updated daily, the FDA calendar gives you insight into FDA actions on companies and upcoming actions the FDA is expected to take. Benzinga's FDA calendar shows historical FDA data, upcoming dates that companies will be impacted by the FDA and ranges of dates. ...
“We appreciate our ongoing engagement with the FDA and look forward to a productive discussion on the clinical evidence supporting the positive benefit-risk profile for pimavanserin as a treatment for ADP at the upcoming Advisory Committee meeting,” Steve Davis, chief executive officer, Acadia, ...
After 2022 produced just 37 new drug approvals—the fewest by the FDA since 2016—the United States regulatorsigned offon a bumper crop of 55 new drugs in 2023. The list was the second longest in FDA history, coming up just shy of the single-year record of 59 approvals, ...
This approval is based on OS and other data from the Phase 3 KEYNOTE-590 trial. Additional details about the upcoming ODAC meeting can be found by visiting the Federal Register or the FDA Advisory Committe...
As promised in the Fall Unified Regulatory Agenda, FDA issued the final rule to establish the pathway to obtain marketing approval of a nonprescription drug product with an additional condition for nonprescription use (ACNU) on December 26, 2024, before the end of the calendar year. … FDA’...
FDA has issued the final guidance, “IRB Continuing Review after Clinical Investigation Approval.” GCP Guidance Documents may be found here:FDA GCP Website. The new guidance is on the right in the section “In The News.” Share this: ...
I downloaded the data set on September 20, 2024, and looked when standards were recognized by FDA and to which therapeutic or functional areas they related. As always, I used calendar years because it’s easier for us nongovernmental people to understand, but that also means that 2...
B. And the disapproval remained strong. C. What comes out is clean enough to drink. D. On the International Space Station, water is a precious resource. E. Lots of people feel sick at the thought of drinking recycled wastewater.
I am writing to inform you of an important notice regarding the upcoming school sports day. As you all know, sports day is a highly anticipated event in our school calendar, and it is a great opportunity for all students to showcase their athletic abilities and team spirit. Therefore, it ...