FDA ALERT
FDA ALERT
03/26/2026
Ashton L. Stahl
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...
03/26/2026
FDA Alert
FDA Alert
03/03/2026
Anthony Calabro, MA
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...
03/03/2026
FDA Alert
FDA Alert
02/25/2026
Kate Young
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...
02/25/2026
FDA Alert
FDA Alert
09/23/2025
Kate Young
The FDA initiated approval of leucovorin calcium tablets to treat cerebral folate deficiency (CFD) following a systematic analysis demonstrating promise in this patient population.
09/23/2025
Public Health
Public Health
05/28/2025
Kate Young
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...
05/28/2025
FDA Alert
FDA Alert
01/29/2025
Miranda Manier, BA
The FDA has proposed new draft guidance to improve the accuracy of pulse oximeters across all skin tones, addressing long-standing concerns about potential disparities in performance.
01/29/2025
FDA Alert
FDA Alert
01/06/2025
Anthony Calabro, MA
Crinecerfont, a first-in-class therapy, improved androgen control and reduced reliance on high-dose glucocorticoids for patients with congenital adrenal hyperplasia.
01/06/2025
FDA Alert
FDA Alert
09/27/2024
Anthony Calabro, MA
The nasal spray is the first vaccine for the prevention of influenza that does not need to be administered by a health care provider.
09/27/2024
FDA Alert
FDA Alert
04/18/2024

Anthony Calabro, MA

Anthony Calabro, MA
The FDA approved givinostat, a nonsteroidal oral medication, for treating patients 6 years of age or older with Duchenne muscular dystrophy.
04/18/2024
FDA ALERT
FDA ALERT
11/30/2023
Anthony Calabro, MA
The FDA approved ustekinumab-auub as an interchangeable biosimilar with ustekinumab for multiple inflammatory diseases.
11/30/2023