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.
Bitcoin's price surged past $84,000 on September 21, closing above its 50-week moving average for the first time in 45 weeks, a key technical milestone that suggests the bear market may be over. Analysts like Alex Thorn and Ted Pillows highlight that...
TRX is trading in a critical pullback zone between $0.3389 and $0.3393, with upside targets at $0.3469, $0.3535, and $0.3611. Derivatives volume and open interest have risen, indicating increased trader activity. Tron Inc. has added 147,132 TRX to it...
VanEck's Bitcoin ChainCheck report highlights Metaplanet's executive option pool at 14.7% of fully diluted shares, far above peers, raising dilution concerns for shareholders. Officer exposure is 8.2%, nearly ten times the average among major Bitcoin...
Cardano's delegated representatives voted down a $12.29 million funding request for Input Output's Pogun project, designed to integrate Bitcoin into decentralized finance. Although the Constitutional Committee unanimously approved the proposal, the D...
Broadcom has declared its next quarterly dividend of $0.65 per share, payable on September 30, 2026, unchanged from the previous quarter. This marks the company's 16th consecutive year of dividend increases, highlighting its commitment to long-term d...
