The FDA has approved Amneal Pharmaceuticals’ ( NASDAQ: AMRX) OTC Naloxone HCl nasal spray, a generic version of the opioid ...
By Chris Wack Amneal Pharmaceuticals shares were up 9% after the Food and Drug Administration approved an abbreviated new drug application ...
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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 ...
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 ...
Enhertu has been approved by the FDA for certain patients with unresectable or metastatic HER2-positive solid tumors. The Food and Drug Administration has granted Enhertu (fam-trastuzumab ...
The US Food and Drug Administration (FDA) has approved the first-ever prescription app for major depressive disorder (MDD). The app, Rejoyn, was developed by Otsuka Pharmaceutical and Click ...
Due to adcomm panel meet, the FDA pushed the approval date for Abecma from 16 December 2023. Abecma helped extend the time before disease progression by 13.3 months vs. 4 months in standard care ...
"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 ...
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 ...
This approval follows the recent recommendation of the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA, whose vote confirmed 13 to 1, with 0 abstention ...