Sun Pharma Advanced Research Company says that Ocuvex Therapeutics has resubmitted an NDA for PDP-716, more than two years after the agency issued a c...
Politico reports that FDA commissioner Marty Makary and HHS secretary Robert F. Kennedy, Jr., are feuding over vaccine safety studies and staffing app...
FDA issues a Warning Letter to Cdymax India Pharma Private Limited after inspectors uncovered CGMP violations at the companys active pharmaceutical in...
Merck reports that its drug Winrevair (sotatercept-csrk) significantly improved a key measure of heartlung function in a mid-stage trial of patients w...
FDA releases the form FDA-483 issued following an inspection at the Milan, Italy-based NerPharMa drug manufacturing facility.
Three stakeholders ask FDA to consider making specific revisions to its draft guidance on new safety labeling change provisions in the Federal Food, D...
Sens. Chris Coons and Ted Budd introduce legislation to promote improvements in U.S. biopharmaceutical manufacturing through a new Center of Excellenc...
FDA launches a new meeting minutes pilot program aimed at reducing delays and confusion that often follow formal meetings between the agency and drug ...
