HHS removes Covid-19 vaccine recommendations for healthy children and healthy pregnant women from CDCs recommended immunization schedule.
FDA places a clinical hold on a Rocket Pharmaceuticals Phase 2 pivotal trial for RP-A501, an investigational gene therapy for Danon disease, following...
FDA gives 510(k) clearance to the latest Olympus endoscopes that feature new extended depth of field technology.
FDA issues Savara a Refusal-to-File (RTF) letter for its BLA for Molbreevi (molgramostim) inhalation solution for treating autoimmune pulmonary alveol...
FDA grants an expanded interchangeable designation for Celltrions Yuflyma (adalimumab-aaty), a biosimilar copy of AbbVies Humira.
BD recalls its Esophagogastric Balloon Tamponade Tubes to update the devices instructions for use due to difficulties in removing plastic plugs from i...
FDA approves Liquidias Yutrepia (Treprostinil), a new inhalation powder designed to treat adults with pulmonary arterial hypertension and pulmonary hy...
FDA approves Roches Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic retinopathy.
