More than three years after Novartis’ plan for a speedy approval for intrathecal Zolgensma was thwarted by an FDA requirement ...

Since Zepbound was approved by the FDA to treat obesity in late 2023, its maker Eli Lilly has been steadily closing in on ...

Marinus Pharmaceuticals, working through a tumultuous period marked by two phase 3 blows, layoffs and a shareholder lawsuit, ...

In a move designed to advance its pipeline and its “innovative medicines business,” Chinese biotech Hutchmed will ...

While the New Year's tradition of drug price hikes has held firm for years, pharma companies have decidedly tamped down on ...

Almost exactly 10 years after the FDA’s initial FDA approval for Bristol Myers Squibb’s Opdivo as the first PD-1 inhibitor in ...

After reinvigorating a decades-old schizophrenia drug in an innovative long-acting treatment option, Teva is looking to ...

Following rapid (and pricey) expansion efforts from Novo and Lilly, plus recent shortage updates at the FDA, “positive ...

The second and more recent probe involves alleged smuggling of unapproved drugs—the Daiichi-partnered HER2 therapy Enhertu ...