FDA staff return to crowded offices, broken equipment and missing chairs
Thousands of Food and Drug Administration employees are returning to the office to find overflowing parking lots, cramped ...
FDA approves Xeris Biopharma’s sNDA of Gvoke VialDx as gastro diagnostic aid
Holdings announced that its supplemental new drug application, sNDA, of Gvoke VialDx has received U.S Food and Drug ...
Business Insider7d
PharmaTher receives FDA approval goal date for ketamine
PharmaTher (PHRRF) has received an Amendment Acknowledgement Letter from the U.S. Food and Drug Administration for its New Drug Application for Ketamine. In the AAL, the FDA determined this is a ...
Food Safety News4d
Senate committee advances Makary to become new head of the FDA
Marty Makary is one step closer to becoming the head of the Food and Drug Administration. On March 13, the Senate Health, Education, Labor and Pensions Committee voted to advance Makary’s ...
BGR6d
A common drug might actually be helping people live longer
If you buy through a BGR link, we may earn an affiliate commission, helping support our expert product labs. Could a simple blood pressure pill be the key to a longer, healthier life? Scientists ...
News Medical5d
How consultants help accelerate drug product development timelines
Variations in regulatory requirements across regions often create inefficiencies in drug development—for example, differences in manufacturing standards and stability testing protocols can lead ...
News-Medical.Net on MSN5d
Clinical trial tests herpes virus-based therapy for neurogenic bladder in people with spinal cord injury
A modified herpes virus that targets spinal cord nerve cells to treat neurogenic bladder in people with spinal cord injury is underway in a first-in-human clinical trial by UTHealth Houston at TIRR ...
pharmaphorum4d
Sanofi claims FDA okay for drug to treat rare blood disorder CAD
Sanofi has won FDA approval for its sutimlimab for cold agglutinin disease (CAD) at the second time of asking, becoming the first approved therapy for the rare blood disorder in the US.
Sky2d
A new drug is causing horror on US streets
One person dies of a drug overdose every five minutes in America. More than 70,000 people a year are already being killed by the opioid Fentanyl. This drug is now being mixed with something even ...
Nature5d
Drug delivery articles from across Nature Portfolio
Lipid nanoparticles have emerged as leading candidates for encapsulating mRNA drugs and have shown success in in vivo applications. Here, the authors provide a step-by-step guide for mRNA lipid ...
Chemistry World6d
Ending of US weight-loss drug shortages prompts compounder complaints
Decision ends pharmacies’ permission to prepare versions of GLP-1 hormone mimics Novo Nordisk’s semaglutide diabetes and weight loss drugs, Ozempic and Wegovy, are no longer officially in shortage in ...
Universiteit Utrecht5d
Drug Innovation
Do you want to know how you can develop new drugs to combat drug-resistant microorganisms? How to find a way to imprint the immune system to increase tolerance? Reducing the side effects of treatment ...