The FDA has accepted for review the NDA for bumetanide nasal spray for edema associated with CHF, as well as hepatic and renal disease.

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 ...

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Vertex Pharma has secured FDA approval for its non-opioid pain drug suzetrigine, becoming the first new class of pain medicine in the US in more than 20 years.

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

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

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

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

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

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