March 5, 2024
The US Food and Drug Administration (FDA) has cleared Dexcom’s Stelo Glucose Biosensor System as the first over-the-counter continuous glucose monitoring (CGM) system. Unlike Dexcom’s G6 […]
March 5, 2024
The PDUFA VII and BsUFA III commitment letters provide an update to the definition of face-to-face formal meetings with industry. This update clarifies that a face-to-face […]
March 5, 2024
Posttraumatic headache (PTH) is associated with an increase in iron accumulation in certain brain regions , notably those involved in the pain network, early research shows. […]
March 5, 2024
Syphilis and chlamydia infections were reduced by half among men who have sex with men and transgender women 1 year after San Francisco rolled out doxycycline […]
March 5, 2024
The investigational RNA interference therapeutic, zilebesiran, has shown positive top-line results in the KARDIA-2 phase 2 study for the treatment of hypertension when added to standard-of-care […]
March 5, 2024
FDA approves first interchangeable biosimilars to Prolia and Xgeva to treat certain types of osteoporosis and prevent bone events in cancer 3/05/2024 Jubbonti and Wyost Denosumab-bbdz […]
March 5, 2024
Speech by Robert M. Califf, M.D., MACC (Remarks as prepared for delivery) Good morning. I’m delighted to be with you today and support your efforts to […]
March 5, 2024
Subscribe for email updates Recommended Acceptable Intake (AI) Limits and Testing Methods On 8/4/2023, FDA issued a final guidance on Recommended Acceptable Intake Limits for Nitrosamine […]
March 5, 2024
The following are common questions and answers about supply chain security requirements of the Drug Supply Chain Security Act. 1. Is the pedigree provision of the […]
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