The FDA has issued a complete response letter for rivoceranib plus camrelizumab as a first-line treatment for unresectable ...

Johnson & Johnson (J&J) has received US Food and Drug Administration (FDA) approval for its interleukin 23 inhibitor, Tremfya ...

Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G) Fabhalta is the only oral alternative complement pathway ...

Amvuttra’s clearance in a rare form of cardiomyopathy could help Alnylam turn a regular profit — if it can wrest control of a ...

A bill under consideration in the legislature would position Iowa to immediately allow prescriptions of a synthetic version ...

Planned single, pivotal Phase 2/3 clinical trial, if positive, acceptable for Biological License Application (BLA) submission for Alzheimer's diseaseAlignment with FDA on proposed trial study design ...

Raziel Green, 52, an active runner and mother of two, was diagnosed with a rare form of ALS in 2017. Since starting a ...

Pharma giant Gilead Sciences has revealed the results of its first, Phase 1 trial into a once-a-year PrEP injection. The ...

Medera is a clinical-stage biopharmaceutical company focused on targeting difficult-to-treat and currently incurable diseases by developing a range of next-generation therapeutics. Medera operates via ...

There’s rosemary, that’s for remembrance,” says Ophelia in Shakespeare’s Hamlet. So it is fitting that researchers would ...

Post the conclusion of this scheduled inspection, the US FDA issued a Form 483 with one procedural observation the companys aforementioned unit. The company will provide comprehensive response to US ...

The FDA cited issues with DexCom's response to prior inspection findings, known as Form 483 observations. The inspections took place at the San Diego facility between October 21 and November 7 ...