By Chris Wack Amneal Pharmaceuticals shares were up 9% after the Food and Drug Administration approved an abbreviated new drug application ...
The FDA has approved Amneal Pharmaceuticals’ ( NASDAQ: AMRX) OTC Naloxone HCl nasal spray, a generic version of the opioid ...
The U.S. Food and Drug Administration (FDA) has approved a new type of medicine for people who aren’t able to control their high blood pressure with other drugs. Tryvio (aprocitentan ...
The U.S. Food and Drug Administration (FDA) has approved a medical device named the Sepsis ImmunoScore, which is an artificial intelligence/machine learning software, to guide rapid diagnosis and ...
Jamie Raskin, D-Md., ranking member of the committee, asked the FDA what it plans to do regarding many products, including lead-contaminated cinnamon applesauce pouches that caused many children ...
The U.S. Food and Drug Administration has approved Dovato (dolutegravir/lamivudine) for adolescents living with HIV. The approval is for the treatment of HIV-1 ...
So, Landgren, who was then working at the National Cancer Institute, helped launch an interagency initiative involving the FDA and the National Heart, Lung and Blood Institute. In 2012 ...
"The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective, and Zevtera will provide an additional treatment option for a number of serious bacterial ...
Dovato is the first oral, two-drug, single-tablet regimen approved for patients 12 years of age and older who are living with HIV-1. ViiV Healthcare has announced the ...
Its GAD device was approved just last week, and its device for insomnia received FDA clearance last October. More products are on the way, including a device for treating obesity-related ...
(Query whether these groups have standing.) The FDA and those groups calling for a ban on menthol cigarettes claim that this will benefit public health, but it's not clear the relevant medical ...
Today, 85% of accelerated approvals go to cancer drugs. It allows the FDA to grant early approval to drugs that show promising initial results for treating debilitating or fatal diseases.