This parasiticide product was previously approved for killing adult fleas ( Ctenocephalides felis ), treating and preventing ...
The median launch prices in the US increased from $29,630 (IQR, $1322-$49,691) for drugs approved in 201 to $84,240 (IQR, ...
The Supreme Court on Monday pressed the Food and Drug Administration on whether it followed the law in its effort to keep ...
In the ongoing case, vaping companies argue that the FDA was “arbitrary and capricious” in rejecting applications for ...
The Food and Drug Administration (FDA) has approved Yesintek TM (ustekinumab-kfce), a biosimilar to Stelara ® (Ustekinumab), for the treatment of various chronic inflammatory diseases. Yesintek, ...
Applied Therapeutics said on Monday it received a warning letter limited to a trial studying its genetic disease drug, after ...
Yesintek is the latest Stelara biosimilar to gain FDA approval and it will be available in February 2025.
The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Applied Therapeutics regarding the New Drug Application (NDA) for govorestat for the treatment of classic ...
With e-cigarette sales booming, the Supreme Court heard arguments over whether the FDA unlawfully blocked approval of more ...
The Supreme Court on Monday heard arguments about the federal regulation of flavored e-cigarettes, in a case pitting the Food ...
We think UCB is in good financial health, with solid earnings and cash flow generation. UCB has deleveraged over the years, and it ended 2023 with about EUR 2.2 billion in net debt on its balance ...
The FDA has approved Rapiblyk, a new drug to treat irregular heartbeats in critically ill hospitalized patients with severe ...