The letter states that the application cannot be approved in its present form.
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However, the Janssen COVID-19 vaccine was associated with increased risk at 21 and 42 days postvaccination
The table provided is a review of notable updates that occurred in January 2023 for investigational products in development.
Belimumab is a B-lymphocyte stimulator-specific inhibitor.
The sNDA is supported by data from the phase 2 PIONEER trial that evaluated the efficacy and safety of avapritinib in patients with indolent systemic mastocytosis.
The new room temperature storage condition for Asceniv and Bivigam is immediately effective.
The table provided is a review of notable updates that occurred in September 2022 for investigational products in development.
The approval was based on data from an expanded access program which evaluated the safety of amifampridine in 21 pediatric patients for at least 1 year.
Leniolisib is a small molecule inhibitor of the delta isoform of the 110 kDa catalytic subunit of class IA PI3K with immunomodulating and potentially antineoplastic activities.
Risk for maternal IBD relapse and prematurity reduced with continuation of anti-TNF after 24 weeks of pregnancy
Most secondary end points did not support the results of the analysis for the primary end point
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The approval was based on data from a phase 1/2 trial that included patients 1 year to less than 22 years of age with cGVHD after failure of 1 or more lines of systemic therapy.
Optic neuritis is a rare autoimmune disease characterized by the inflammation of the optic nerve.
The Food and Drug Administration (FDA) has expanded the approval of Benlysta (belimumab) to include pediatric patients 5 to 17 years of age with active lupus nephritis who are receiving standard therapy. Benlysta, a B-lymphocyte stimulator (BLyS)-specific inhibitor, is also indicated for the treatment of patients 5 years of age and older with active systemic…
Adjusted rate ratio of 20.56 found in head-to-head comparison of Ad.26.COV2.S with mRNA COVID-19 vaccines
In preclinical studies, efzofitimod was found to prevent inflammation and fibrosis in multiple animal models of systemic sclerosis and idiopathic pulmonary fibrosis.
The new expiration date for Asceniv and Bivigam is immediately effective and applies to all existing lots currently in the commercial supply chain and to future production.