FDA puts a clinical hold on an AstraZeneca trial of an investigational blood cancer drug after heart concerns were reported in one patient.
Merck recalls one lot of Cubicin (daptomycin for injection) 500mg for intravenous use due to a complaint being received about a piece of glass found i...
FDA approves Regeneron Pharmaceuticals and Sanofis Dupixent (dupilumab) as an add-on maintenance treatment for certain patients aged six to 11 years w...
FDA approves an Esteve Pharmaceuticals NDA for Seglentis (celecoxib and tramadol hydrochloride) for treating acute pain in adults.
CDCs Advisory Committee for Immunization Practices votes to recommend accepting FDAs 10/20 amended emergency use authorizations for booster doses of b...
The House passes Rep. Pallones bipartisan National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing legislation.
FDA sends Stealth BioTherapeutics a refuse to file letter on its NDA for elamipretide, a mitochondria-targeted therapy for treating Barth syndrome.
FDA warns Magnolia Medical Technologies about Quality System regulation violations in its work as a specification developer for a blood collection sys...