Tag: FDA
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 ... Read More
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 ... Read More
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) ... Read More
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 ... Read More
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 ... Read More
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) ... Read More
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 ... Read More
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 ... Read More
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 ... Read More
AstraZeneca gets FDA breakthrough status for Farxiga in CKD
AstraZeneca has been granted breakthrough therapy designation (BTD) for Farxiga (dapagliflozin) from the US Food and Drug Administration (FDA) for the treatment of patients with ... Read More