OR WAIT null SECS
June 27, 2016
ICH detailed the highlights of the council’s June 2016 meeting.
June 24, 2016
The agency is following up on a February 2016 inspection of the facility that found GMP violations.
The agency recommends Zalmoxis, a new cell-based therapy to support stem cell transplantation in patients with high-risk blood cancer.
The agency has suspended recommendation of Riluzole Alkem due to flawed study results.
June 23, 2016
China’s State Council issued a notice authorizing a trial plan for a new drug marketing authorization holder system for 10 provinces.
June 22, 2016
The two agencies have set up a working group on involving patients in drug development.
June 10, 2016
Mandatory use of the periodic safety update report repository becomes mandatory on June 13.
June 09, 2016
Sharing un-redacted inspection reports between FDA and EMA may reduce duplicate inspections of facilities.
June 01, 2016
Pharma has voiced strong opposition against Britain’s departure from the EU.
May 31, 2016
Samsung Bioepis and partner Biogen announced on May 30 that the European Commission approved Flixabi for the treatment of six inflammatory conditions.