The drug, suzetrigine, made by Boston-based Vertex Pharmaceuticals and to be sold as Journavx, works only on nerves outside ...

The FDA clearance aids AstraZeneca and Daiichi Sankyo’s plan to position ADCs like Enhertu ahead of chemotherapy in a variety ...

People with treatment-resistant depression can now take Spravato's ketamine-derived nasal spray as a standalone treatment.

On January 16, 2025, the U.S. Food and Drug Administration (“FDA”) published a highly anticipated proposed rule on front-of-package (“FOP”) ...

Meanwhile, in an executive order, Trump created his long-discussed “Department of Government Efficiency,” to be led by Elon ...

The U.S. Food and Drug Administration has upgraded a recall of salmon sold at Costco to Class I, its highest threat level.

The US Food and Drug Administration (FDA) has approved the abbreviated new drug application (ANDA) of Lupin’s Sacubitril and ...

After years of legal wrangling surrounding Teva’s Copaxone, the latest hit to the lucrative multiple sclerosis drug comes in ...

Lots of people are on cheaper compounded weight-loss drugs that mimic brands like Ozempic, Wegovy, and Zepbound. They're ...

The Federal Circuit has issued a precedential decision reversing a lower court’s decision that certain claims of Novartis’s ...

Despite receiving a prior wrist slap from the FDA in the shape of a Form 483, Sanofi is still working to right the ship at a ...