The FDA has approved Zolgensma (onasemnogene abeparvovac-xioi; Novartis) for the treatment of children less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene.
The Food and Drug Administration (FDA) has approved the use of Corlanor (ivabradine; Amgen) for the treatment of stable symptomatic heart failure (HF) due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate.
The Food and Drug Administration (FDA) has granted Breakthrough Status designation to NightWare (NightWare, Inc.), a digital intervention therapy that measures and treats nightmares in patients with post traumatic stress disorder (PTSD).
The FDA has approved a revised product label for Octaplas (Octapharma), Pooled Plasma (Human), Solvent/Detergent Treated Solution for Intravenous Infusion.
Agile Therapeutics has resubmitted to the Food and Drug Administration (FDA) the New Drug Application (NDA) for its product, Twirla, an investigational low-dose combined hormonal contraceptive patch (AG200-15). Based on the results from a comparative wear study, the resubmitted NDA will address the FDA’s questions on in vivo adhesion, additional information on the Company’s manufacturing…
The FDA has expanded the indication of Gattex (teduglutide; Shire) for injection in pediatric patients ≥1 year of age with Short Bowel Syndrome who need additional nutrition or fluids from intravenous (IV) feeding (parenteral support).
The Food and Drug Administration (FDA) has recommended that ImmunoGen, Inc. conduct a new phase 3 randomized trial to evaluate the safety and efficacy of mirvetuximab soravtansine (IMGN853) in patients with high folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer.
