Browsing Tag
US Food and Drug Administration
348 posts
Abbott ID NOW COVID-19 test gets FDA nod to detect coronavirus in 5 mins
Abbott ID NOW COVID-19 test : Medical device company Abbott has been granted Emergency Use Authorization (EUA) for…
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…
Thermo Fisher coronavirus diagnostic test gets FDA’s emergency use order
Thermo Fisher Scientific has been granted an emergency use authorization (EUA) for its coronavirus diagnostic test from the…
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…
Cerovene bags FDA approval for Daraprim generic for toxoplasmosis treatment
Cerovene has bagged approval from the US Food and Drug Administration (FDA) for its generic version of Daraprim…
Lilly bags Trulicity FDA approval for reducing CV risk in type 2 diabetes patients
Trulicity FDA approval : Eli Lilly and Company (Lilly) has secured approval from the US Food and Drug…
PADCEV, KEYTRUDA combination for advanced bladder cancer gets FDA breakthrough therapy status
PADCEV, KEYTRUDA combination : Astellas Pharma and Seattle Genetics said that the combination of PADCEV (enfortumab vedotin-ejfv) and…
Epizyme gets FDA priority review for TAZVERIK in follicular lymphoma
Epizyme has been granted priority review by the US Food and Drug Administration (FDA) for the use of…