Browsing Tag
FDA
293 posts
Cipla gets FDA’s final approval for generic version of Migranal with CGT designation
Cipla has secured final approval for its abbreviated new drug application (ANDA) for Dihydroergotamine Mesylate Nasal Spray 4mg/mL…
Quidel’s Lyra Direct SARS-CoV-2 Assay gets FDA EUA status for molecular detection of COVID-19
Quidel has been given emergency use authorization from the US Food and Drug Administration (FDA) for its Lyra…
No drops, no plugs: How the iTEAR100 device triggers tears in 30 seconds
Olympic Ophthalmics secures FDA clearance for iTEAR100, a handheld neurostimulator that activates tear production in seconds. Find out how it could transform dry eye treatment.
Selpercatinib FDA approval : Lilly’s therapy approved for treatment of lung and thyroid cancers with RET alteration
Selpercatinib FDA approval : The US Food and Drug Administration (FDA) has approved Eli Lilly and Company’s Retevmo…
FDA grants EUA for Gilead’s investigational COVID-19 drug remdesivir
Remdesivir EUA status : The US has officially pushed the use of remdesivir for treating the novel coronavirus…
GS COVID-19RT-PCR diagnostic test : GenoSensor secures FDA EUA status
COVID-19 diagnostic test : GenoSensor has been granted emergency use authorization status from the US Food and Drug…
Actemra coronavirus clinical trial : Genentech gets FDA nod for COVID-19 trial
Actemra coronavirus clinical trial : Genentech has been given approval by the US Food & Drug Administration (FDA)…
Gilead Sciences bags Epclusa FDA approval for hepatitis C in pediatric patients
Epclusa FDA approval : Gilead Sciences has secured an expanded approval for Epclusa (sofosbuvir 400mg/velpatasvir 100mg; sofosbuvir 200mg/velpatasvir…
F2G’s olorofim gets FDA ODD for mold infections and Valley Fever
F2G has bagged orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for olorofim (formerly…
FDA approves Opdivo + Yervoy for HCC previously treated with sorafenib
Bristol Myers Squibb has secured approval for the combination of Opdivo (nivolumab) 1 mg/kg and Yervoy (ipilimumab) 3…