Browsing Tag
US Food and Drug Administration
333 posts
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…
March 12, 2020
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…
March 2, 2020
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…
February 22, 2020
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…
February 20, 2020
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…
February 17, 2020
Olympus secures FDA clearance for TJF-Q190V duodenoscope
Olympus Medical Systems Group has secured clearance from the US Food and Drug Administration (FDA) for its TJF-Q190V…
February 9, 2020
CATALYST clinical trial : FDA approves Abbott’s trial of Amplatzer Amulet device in AF
Abbott has been granted approval from the US Food and Drug Administration (FDA) for the CATALYST clinical trial…
February 4, 2020
Aimmune Therapeutics bags Palforzia FDA approval for peanut allergy
Palforzia FDA approval : Aimmune Therapeutics has been granted approval from the US Food and Drug Administration (FDA)…
February 3, 2020
TenNor Therapeutics gets FDA orphan drug status for TNP-2092 in prosthetic joint infections
TenNor Therapeutics has secured orphan drug designation from the US Food and Drug Administration (FDA) for its multitargeting…
January 21, 2020
Arena Pharmaceuticals’ APD418 gets FDA fast track status in decompensated heart failure
Arena Pharmaceuticals has secured that fast track designation for its drug candidate APD418 from the US Food and…
January 19, 2020