A federal jury awarded Insulet Corp. $452 million against Eoflow Co. Ltd., concluding that Eoflow and other defendants stole ...
A ketone body, a molecule derived from the metabolism of acids to obtain energy when glucose is not available, could become ...
Merus NV gained accelerated U.S. FDA approval of Bizengri (zenocutuzumab) as the first and only targeted therapy indicated for NRG1-positive pancreatic adenocarcinoma and non-small-cell lung cancer ...
Methods that may work well for recruiting and retaining white patients for clinical trials may need to be adjusted to ...
Spur Therapeutics Ltd. has selected SPR-301 as lead development candidate from its gene therapy program for a genetically ...
Beacon Biosignals Inc. can rest easy now that it has received U.S. FDA authorization of its predetermined change control plan ...
In breast cancer, neoadjuvant chemotherapy reduces the tumor before surgery. However, the response to this treatment does not ...
Novartis AG lost its bid, at least for now, to delay generic competition to its blockbuster heart drug, Entresto (sacubitril, valsartan), on the basis of patent infringement.
At long last, the U.S. FDA finalized guidance on using predetermined change control plans in submissions for medical devices that include artificial intelligence. The guidance, “Marketing Submission ...
The U.K.'s Medicines and Health Care Products Regulatory Agency chose five technologies for its AI Airlock pilot program as it looks to understand the best way to regulate artificial ...
The U.S. CMS has negotiated outcomes-based agreements with Bluebird Bio Inc. and Vertex Pharmaceuticals Inc. to make their costly sickle cell gene therapies the first treatments to become available ...
Elevar Therapeutics Inc. will license Relay Therapeutics Inc.’s “NDA-ready” bile duct cancer therapy, lirafugratinib (RLY-4008), through a potential $500 million deal as Elevar, an HLB Co. Ltd.