Regulatory
The agency approved Evenity on the basis of two Phase III clinical trials. The drug had been rejected in 2017 over safety concerns.
PhaseBio Pharmaceuticals, based in Malvern, Penn. and San Diego, announced that its antiplatelet drug PB2452 had received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA).
Zogenix said the FDA determined that the NDA, which was submitted in February, was not “sufficiently complete to permit a substantive review.”
The U.S. Food and Drug Administration (FDA) approved ViiV Healthcare’s Dovato, a once-a-day, single-tablet combination of dolutegravir (DTG) and lamivudine (3TC) for HIV-1 in adults who had not received treatment before.
Eisai Co., Ltd. has announced that its in-house discovered fibroblast growth factor receptor tyrosine kinase inhibitor E7090 has been granted the SAKIGAKE designation by Japan’s Ministry of Health, Labour and Welfare for the treatment of unresectable biliary tract cancer with FGFR2 gene fusion.
Celgene and its developmental partner Acceleron Pharma are eying a potential U.S. Food and Drug Administration approval of a blood-disease treatment.
The FDA calendar has only one PDUFA data scheduled for the next couple weeks. On Thursday, April 11, the U.S. Food and Drug Administration (FDA) and Merck & Co. have a target action date for their supplemental Biologics License Application (sBLA) for Keytruda
“Men with breast cancer have limited treatment options, making access to medicines such as Ibrance critically important,” stated Bret Miller, founder of the Male Breast Cancer Coalition.
Sino-American relations continue to show signs of strain after the administration of President Donald Trump ordered the Chinese majority owner of healthcare company PatientsLikeMe to sell his stake.
The Pennsylvania-based company disagrees with the FDA’s analysis of its clinical data and will seek to work with the agency for approval.
PRESS RELEASES