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 ...
WHAT DOES THE FDA APPROVAL MEAN? Narcan will become available over-the-counter by late summer, the company said. Other brands of naloxone and injectable forms will not yet be available over the ...
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 ...
Merck expects that Winrevair should be available in select specialty pharmacies by the end of next month. 1 1. FDA Approves Merck’s WINREVAIR™ (sotatercept-csrk), a First-in-Class Treatment for Adults ...
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 ...
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 ...
(RTTNews) - Amneal Pharmaceuticals, Inc. (AMRX) announced on Wednesday that it has received FDA approval for its Over the Counter ... Nasal Spray is a generic version of the widely used OTC NARCAN HCI ...
"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 ...
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 ...
devastating disease for individuals impacted by DMD regardless of genetic mutation," Emily Freilich, M.D., of the FDA Center for Drug Evaluation and Research, said in a statement.