The FDA completed the first-cycle review of NRx Pharmaceuticals' preservative-free ketamine ANDA with no major deficiencies related to the drug product, ingredients, labeling, or manufacturing. The only remaining issue is a packaging certification for the vial's luer lock system, which is already used in approved products with millions of units shipped without complaints. No new clinical or safety data are required, and the FDA has committed to a rapid review of this packaging certification. This milestone significantly reduces regulatory risk and moves the drug closer to approval amid a national ketamine shortage and increased demand for preservative-free options.
Imbal hasil Treasury 10 tahun AS mencapai level tertinggi sejak 2007, memicu kekhawatiran akan kerentanan di sektor perumahan, properti komersial, dan perusahaan dengan utang besar. Para ahli memperingatkan bahwa dampak terburuk akan terasa dalam 12-...
HIVE Digital Technologies, through its subsidiary BUZZ HPC, has formed a strategic partnership with ProCogia, an applied-AI and data engineering company. This collaboration will see ProCogia utilizing BUZZ HPC's Canadian data centers to provide AI so...
Axon Enterprise, a public safety technology company, has priced an offering of $1 billion in 0% convertible senior notes due 2031. The company expects to receive approximately $986 million in net proceeds, which will be used to cover the cost of capp...
Oil prices declined after a report showed an unexpected increase in U.S. crude, gasoline, and distillate inventories last week. This overshadowed concerns about potential supply disruptions following an attack on Saudi Arabia's East-West pipeline by ...
Grab mengakuisisi 60% saham Atome Financial senilai $1,49 miliar secara tunai, dengan rencana untuk membeli sisa 40% dalam waktu sekitar dua tahun. Akuisisi ini bertujuan untuk memperluas layanan keuangan Grab, khususnya di bidang pinjaman konsumen, ...
