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As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Read More
An artificial intelligence platform can discern epileptic seizure patterns on electroencephalogram as well as an expert epileptologist, with nearly 100 percent accuracy, a finding that could extend expert diagnoses to clinics without access to specialists in epilepsy, according to a report in JAMA Neurology. Read More
Dose optimization for pediatric cancer drug trials shouldn’t rely on exhaustive analyses of toxicity, the FDA says, and members of an advisory subcommittee on pediatric oncology agree that children can’t wait for every question to be answered. Read More
Coherus BioSciences has resolved a key piece of its dispute with AbbVie over plans to market Yusimry (adalimumab-aqvh), a biosimilar for AbbVie’s blockbuster immunotherapy Humira, enabling it to begin selling the product July 1 at an 85 percent discount from AbbVie’s price. Read More
Failure to establish corrective and preventive action (CAPA) plans tops the list of devicemakers’ FDA inspection observations year after year, but the situation is more nuanced than you might expect, according to one regulatory expert. Read More
Two clinical trials of Mersana Therapeutics’ ovarian cancer drug UpRi (upifitamab rilsodotin) are on a partial clinical hold from the FDA because of five deaths linked to serious bleeding. Read More
The industry association representing pharmacy benefit managers (PBM) has fired back at the introduction of a Senate bill that would curtail their revenue based on the price of the drugs they manage, pointing the finger instead at drug companies that set high prices. Read More
Ironwood Pharmaceuticals’ Linzess (linaclotide) is the first drug to receive FDA approval to treat functional constipation in children age six to 17 years with a recommended daily dosage of 72 mcg orally. Read More
A dozen states have signed on to Illumina’s appeal of the Federal Trade Commission’s (FTC) order that the company divest itself of Grail — developer of the Galleri early cancer screening test — arguing that the commission’s process in the case was unconstitutional. Read More