InvestorPlace - Stock Market News, Stock Advice & Trading Tips In the biotech and pharmaceutical world, FDA approval is the ...
The Sepsis ImmunoScore was approved through the agency’s De Novo pathway, the process the FDA uses for novel medical devices. Poole said the company plans to sell the Sepsis ImmunoScore at ...
This is the first new type of treatment for the disease approved in nearly a decade, and is considered by the FDA to be “first in class,” meaning it’s the first medicine of its kind to treat ...
The Food and Drug Administration is signing off on a first prescription digital treatment to help with depression.
Wednesday, the FDA approved Akebia Therapeutics Inc (NASDAQ:AKBA) Vafseo (vadadustat) tablets for anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least ...
Duvyzat (givinostat) is histone deacetylase inhibitor that was previously granted priority review, orphan drug designation, and rare pediatric disease designation by the FDA for patients 6 years of ...
The FDA has approved the first drug to treat liver inflammation. The new medication will be sold under the brand name Rezdiffra. Liver inflammation happens when the liver becomes inflamed because ...
Fanapt was previously approved by the FDA in 2009 as an antipsychotic treatment for schizophrenia. The FDA has approved Vanda Pharmaceuticals’ Fanapt (iloperidone) for the acute treatment of manic or ...
opens new tab antibiotic for bacterial infections including multidrug-resistant strains, the FDA said on Wednesday. The Switzerland-based company was seeking approval of its antibiotic ...
, opens new tab drug to treat manic and mixed episodes associated with a type of bipolar disorder, the company said on Tuesday, marking the second approval for the treatment. Shares of the ...
The US Food and Drug Administration (FDA) has approved iloperidone tablets (Fanapt) for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. Iloperidone is ...
Vanda Pharmaceuticals announces the FDA approval of iloperidone (Fanapt) for the acute treatment of bipolar 1 disorder. Iloperidone is a second-generation atypical antipsychotic agent for managing ...