FDA issues Coherus BioSciences a complete response letter on its BLA supplement for Udenyca Onbody, the companys on-body injector presentation of Uden...
After suffering severe tornado damage at its Rocky Mount, NC plant, Pfizer says it has now restarted most manufacturing lines.
FDA releases a two-item Form FDA-483 citing GMP issues documented at Novo Nordisks Clayton, NC facility during a 7/6-13 inspection.
It appears more likely that the federal government, including FDA, will face a 10/1 shutdown due to a Congressional impasse to approve an appropriatio...
Federal Register notice: FDA makes available a draft guidance entitled Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.
Federal Register notice: FDA makes available a draft guidance entitled Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pendin...
FDA approves Boehringer Ingelheim and Eli Lillys Jardiance (empagliflozin) 10 mg tablets for treating certain patients with chronic kidney disease.
Senators Edward Markey (D-MA) and Joe Manchin (D-WV) call on FDA to curb the use of enriched enrollment randomized withdrawal studies to support opioi...
