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 ...
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 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 ...
"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 ...
"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 ...
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 ...
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 ...