Holdings announced that its supplemental new drug application, sNDA, of Gvoke VialDx has received U.S Food and Drug ...

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 ...

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 ...

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 ...

Variations in regulatory requirements across regions often create inefficiencies in drug development—for example, differences in manufacturing standards and stability testing protocols can lead ...

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 ...

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.

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 ...

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 ...

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 ...

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 ...