The FDA removed previously issued draft guidance on diversity in clinical trials from its website without public notice or ...

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

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 ...

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

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 ...

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

The boy's family believes his sickness was caused by an E. coli outbreak linked to romaine lettuce that affected 88 people ...