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Janssen secures DARZALEX FASPRO FDA approval for AL amyloidosis

Janssen secures DARZALEX FASPRO FDA approval for AL amyloidosis

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 gets FDA approval for Tagrisso for type of NSCLC

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 […]

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Alligator Bioscience gets FDA approval for IND application of mitazalimab

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 […]

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Bamlanivimab Covid-19 drug candidate : Lilly, UnitedHealth Group join forces for pragmatic study

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 […]

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Ensemble CMC Implant : Ensemble Orthopedics gets FDA 510(k) clearance

Ensemble Orthopedics has secured 510(k) clearance from the US Food and Drug Administration for its Ensemble CMC Implant for the treatment of patients with early-stage osteoarthritis of the carpometacarpal (CMC) joint. According to the Texas-based medical device company, the Ensemble CMC Implant has a saddle shape that replaces the natural bearing surfaces of the carpal […]

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Novo Nordisk gets Saxenda FDA updated label to cover obesity treatment in adolescents

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 […]

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FDA extends PDUFA for Pegunigalsidase alfa (PRX–102) in Fabry disease

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 […]

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FDA accepts BLA for Lucentis referencing ophthalmology biosimilar SB11

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. […]

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AstraZeneca gets BRILINTA FDA approval for reducing risk of stroke in acute ischemic stroke or high-risk transient ischemic attack

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 […]

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Gilead Sciences bags Remdesivir FDA approval for Covid-19 treatment

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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