When the FDA announced in January, before President Joe Biden's term ended, that it would ban a dye called red dye No. 3 in ...

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 ...

Lifeward (LFWD) has received 510(k) FDA clearance for the newest generation of its personal exoskeleton device, the ReWalk 7. The seventh generation of the ReWalk, a wearable exoskeleton that ...

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 ...

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

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 ...

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 ...

While supporters dubbed his arrest “unlawful", reactions from those who opposed Duterte’s drug war were jubilant. One group working to support mothers of those killed in the crackdown called the ...