DARZALEX FASPRO FDA approval for AL amyloidosis : Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, has secured approval from the US Food and Drug Administration (FDA) for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide, and dexamethasone (D-VCd) for the treatment of light chain (AL) amyloidosis, which has been newly diagnosed in […]
AstraZeneca has secured extended approval from the US Food and Drug Administration for using Tagrisso (osimertinib) as an adjuvant treatment of non-small cell lung cancer (NSCLC) in patients whose tumors have a certain type of genetic mutation. According to the FDA, nearly 20% of patients with non-small cell lung cancer will have epidermal growth factor […]
Continue reading …Alligator Bioscience said that the investigational new drug application for its CD40 targeting antibody mitazalimab has been approved by the US Food and Drug Administration (FDA). The IND approval enables the Swedish biotech company to begin clinical trials for mitazalimab in the US. According to Alligator Bioscience, a new benchmark data was recently published which […]
Continue reading …Eli Lilly and Company (Lilly) has entered into a partnership with managed care company UnitedHealth Group to carry out a pragmatic study of bamlanivimab (LY-CoV555) in high-risk, Covid-19 infected individuals. Recently, bamlanivimab was granted emergency use authorization (EUA) from the US Food and Drug Administration for the treatment of Covid-19 patients having mild to moderate […]
Continue reading …Novo Nordisk has been given approval from the US Food and Drug Administration (FDA) for an updated label for Saxenda (liraglutide) injection 3 mg for obesity treatment in adolescents in the 12–17 years age group. The approval is for adolescents who weigh more than 60 kg and have an initial body mass index (BMI) corresponding […]
Continue reading …Pegunigalsidase alfa (PRX–102) update : Protalix BioTherapeutics said that the US Food and Drug Administration (FDA) has extended the prescription drug user fee act (PDUFA) date for review of pegunigalsidase alfa (PRX–102) as a treatment of adults with Fabry disease. The PDUFA action date for reviewing the company’s biologics license application (BLA) has been extended […]
Continue reading …Samsung Bioepis and Biogen said that the US Food and Drug Administration (FDA) has accepted for review the biologics license application for SB11, a proposed ophthalmology biosimilar referencing Genentech’s Lucentis (ranibizumab). Ranibizumab is an anti vascular endothelial growth factor (VEGF) therapy for retinal vascular disorders, which are a major cause of blindness in the US. […]
Continue reading …BRILINTA FDA approval : AstraZeneca has bagged approval for BRILINTA (ticagrelor) from the US Food and Drug Administration for its use in reducing the risk of stroke in patients having acute ischemic stroke or high-risk transient ischemic attack (TIA). The FDA approval was driven by the positive results from the THALES phase 3 clinical trial […]
Continue reading …Remdesivir FDA approval : Gilead Sciences, a California-based biopharma company, has bagged approval from the US Food and Drug Administration (FDA) for its antiviral drug Veklury (remdesivir) for Covid-19 treatment in patients requiring hospitalization. This makes remdesivir the first approved treatment for coronavirus in the US. Remdesivir FDA approved indication : Veklury has been approved […]
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