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The company received complaints that the ligation loop can become unintentionally anchored in place.

The Government Accountability Office successfully enrolled 18 out of 20 fake applicants in subsidized ACA plans. Republicans jumped on the report as ammunition in the debate over expanded subsidies.

With the U.S. authorization for urologic procedures, “there is now choice” for hospitals that want to expand their robotic programs, a company executive said.

Investor optimism has waned as final minutes from uniQure’s pre-BLA meeting with the FDA convey that data from the company’s Phase I/II studies of AMT-130 are “unlikely” to provide the primary evidence to support a biologics license application.

Hidden in Republicans’ ACA bashing during a Wednesday health committee hearing were some signs that a clean extension of more generous subsidies isn’t completely off the table — though one still doesn’t look likely.

The deal, first announced in July, includes outreach laboratory services in 13 states. CHS will continue to operate inpatient and emergency department labs.

The partnership will focus on Crescent’s PD-1/VEGF inhibitor CR-001 and Kelun-Biotech’s SKB105, both of which the companies plan to push into Phase I/II development for solid tumors early next year.

Writing in separate editorials in The New England Journal of Medicine and The Journal of the American Medical Association, former chiefs of federal scientific agencies issued warnings about the changes being proposed to vaccine frameworks by current officials.

The regulator is still investigating “additional adverse event cases,” a spokesperson told Endpoints News on Wednesday.

Companies who run their early-stage clinical development outside the U.S. would “experience higher fees” according to an FDA proposal made during the negotiation process for the eighth cycle of the user fee program.