Author name: Leonardo Arias

The data breach is one of the largest healthcare incidents reported to federal regulators this year.

After a busy summer of surgical robotics news, check out MedTech Dive’s roundup of coverage in the space.

The trade group wants the U.S. to eliminate tariffs on medical technologies, warning that “patients cannot be collateral damage in trade tensions.”

With results from highly anticipated trials of Eli Lilly’s orforglipron and Viking Therapeutics’ VK2735 “underwhelming” investors, William Blair’s Andy Hsieh predicts weight loss pills will play a bigger role in low- and middle-income countries than in the U.S.

While it’s impossible to make apples-to-apples comparisons of the many obesity candidates with so many differences across clinical trials, we at BioSpace are giving it our best shot.

There’s still much more to come from the White House on tariffs, but the European Union has now reached a trade agreement with the U.S.

Krystal Biotech’s decision follows the FDA’s rejection last month of Replimune’s RP1, which works similarly to Krystal Biotech’s KB707. The biotech said this has introduced “heightened uncertainty” regarding a potential accelerated pathway for the candidate.

Vanda claims that two generics to its sleep disorder drug Hetlioz were approved despite inadequate data and is requesting that FDA Commissioner Marty Makary revisit the decision.

The drug, for hereditary angioedema, is Ionis’ second wholly owned asset.

Among the problems cited were cat hair, bacterial contamination and instrument defects.