Oblato says FDA has given positive detailed responses on plans for a Phase 1/2 trial of a new treatment for a rare pediatric cancer.
CDERs Office of Prescription Drug Promotion notifies Azurity about violations in a healthcare professional e-mail for the companys Xatmep.
FDAs Vaccines and Related Biological Products Advisory Committee votes to recommend an Emergency Use Authorization for Pfizer-BioNTechs Covid-19 vacci...
FDA grants X4 Pharmaceuticals a rare pediatric disease designation for mavorixafor for treating WHIM (Warts, Hypogammaglobulinemia, Infections, and My...
FDA accepts for filing an Atox Bio NDA for reltecimod to treat patients with necrotizing soft tissue infections.
Swedish researchers say they found no significant increase in the risk of death in patients who received paclitaxel-coated devices to treat peripheral...
Stakeholders support an FDA recommendation to include premenopausal women in breast cancer drug development programs.
CBER director Peter Marks says FDA plans to warn patients whove had previous severe reactions after being vaccinated about such risks with Pfizer-BioN...