The FDA removed previously issued draft guidance on diversity in clinical trials from its website without public notice or ...
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 ...
The confirmatory IGNYTE-3 trial is assessing RP1 in combination with nivolumab in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for ...