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...
FDA accepts for priority review a Pfizer BLA for its 20-valent pneumococcal conjugate vaccine and its us for preventing invasive disease and pneumonia...
FDA grants SoniVie a breakthrough device designation for the Tivus System for renal artery denervation and its use in treating resistant hypertension.
Attorney T. Daniel Logan analyzes the impact on FDA of HHS regulations on good guidance practices.