Avicenna.ai SAS received U.S. FDA clearance for its Cina-Cspine algorithm, which uses machine learning technology to detect ...

After disclosing data from the phase II Herald study, Aligos Therapeutics Inc. may sign a partner to help advance ALG-055009, a thyroid hormone receptor (THR) beta agonist, in subjects with metabolic ...

As med-tech startups look to raise capital without diluting the valuation of their company, many may look to sell ...

Australia is the skin cancer capital of the world, but with a shortage of dermatologists, patients often wait too long to get ...

Wall Street apparently wanted more from Prelude Therapeutics Inc.’s phase I data with SMARCA2 enzyme degrader PRT-3789 in ...

The U.S. CMS believes it has a quandary on its hands with regard to transitional pass-through payment for renal denervation devices, but the Medical Device Manufacturers Association urged the agency ...

Innovent Biologics Inc. unveiled for the first time safety and efficacy data of IBI-354, an HER2 monoclonal ...

What comes down must go up seems to be the rule of thumb these days, even for U.S. FDA fees. The cost of using a priority review voucher (PRV) to shave four months off an FDA standard 10-month drug ...

The U.S. Court of Appeals for the Federal Circuit reined in a district court that invalidated three claims in an Astellas Pharma Inc. patent protecting bladder drug Myrbetriq (mirabegron) based on a ...

Positive data from two studies boosted Edgewise Therapeutics Inc.’s market share and elevated analyst enthusiasm for the company and its treatment of obstructive hypertrophic cardiomyopathy. Top-line ...

Roivant Sciences Ltd. has sold another company, this time offering up Dermavant Sciences Ltd. to Organon & Co. for $1.2 ...

Clearly frustrated by the U.S. FDA’s rejection of tradipitant to treat gastroparesis, Vanda Pharmaceuticals Inc. CEO Mihael Polymeropoulos said the agency is discouraging drug development for the ...