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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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 ...
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 ...
Amneal Pharmaceuticals, Inc. (AMRX) announced on Wednesday that it has received FDA approval for its Over the Counter Naloxone ...
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 ...
, 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 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 ...