Food and Drug Administration (FDA)

The price of the one-and-done gene therapy treatment is about half of what was initially projected by Novartis.

Shares of NovoCure are up more than 6% in premarket trading after the company announced it won regulatory approval for its mesothelioma treatment, NovoTTF-100L System.

“Within this total, the Committee provides target increases for medical product and food safety activities, including new initiatives to revolutionize the safety of the nation’s blood supply and to enable faster responses to foodborne illness outbreaks,” the House Committee said in a statement. “In addition, the bill includes a strong focus on continuing the FDA’s efforts to advance generic drug reviews and increase medical product manufacturing in the U.S.”

Synlogic is partnering with Roche to develop Synlogic’s SYNB1891 with Roche’s checkpoint inhibitor Tecentriq (atezolizumab) in advanced solid tumors.

Sorilux was approved for the treatment of patients age 12 and up.

FDA Chief of Staff Lauren Silvis indicated the FDA is “pushing forward” with its nonprescription safe use regulatory expansion (NSURE) program, and that “OTC monograph reform remains a top priority for the agency” but “it’s up to Congress to legislate the issue.”

The FDA approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) as the first treatments for transthyretin-meditated amyloidosis.

Former commissioner of the U.S. Food and Drug Administration, Scott Gottlieb, although not running for office (that we are aware of), recently published commentary urging the United States to avoid making it more difficult for poor people to gain access to cutting-edge medications.

The FDA extended the indication for Gattex to pediatric patients one year of age and older with short bowel syndrome.