Pediatric safety and pharmacokinetic findings supported expanding leniolisib to children aged 4 to 11 years who weigh at least 27 kg, establishing the first FDA-approved treatment for activated...
Clinical and pharmacokinetic evidence supported approval of zilganersen across pediatric and adult age groups, providing the first therapy designed to reduce production of the abnormal GFAP protein...
The FDA expanded approval of exagamglogene autotemcel (Casgevy) for patients aged 2 years and older with sickle cell disease and recurrent vaso-occlusive crises or transfusion-dependent β-thalassemia.
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March 2026 included several FDA drug and biologic approvals across a range of therapeutic areas. This timeline highlights the key alerts our publication covered throughout the month, giving readers a quick,...
The FDA has approved Avlayah (tividenofusp alfa-eknm) for certain pediatric patients with Hunter syndrome, marking the first approval targeting the disease's neurologic complications and offering clinicians...
On March 3, 2026, the FDA approved the first generic of Flovent HFA (fluticasone propionate) inhalation aerosol, 44 mcg per actuation, for the maintenance treatment of asthma as prophylactic therapy in...
The FDA has approved dupilumab (Dupixent) for the treatment of allergic fungal rhinosinusitis, a rare form of chronic sinus inflammation driven by hypersensitivity to fungal organisms in the sinuses, in...
The FDA initiated approval of leucovorin calcium tablets to treat cerebral folate deficiency (CFD) following a systematic analysis demonstrating promise in this patient population.
Secretary Robert F. Kennedy Jr. announced that the CDC will no longer recommend the COVID-19 booster vaccine for healthy children and pregnant people. The announcement comes despite previous CDC...
