Nicole DeFeudis

The FDA overstepped its authority when it issued a rule last May to bring laboratory-developed tests under the agency’s regulation, a Texas federal court held on Monday.

A federal judge on Monday dismissed a Johnson & Johnson subsidiary’s third attempt to settle tens of thousands of talc cases through bankruptcy.

The Senate on Thursday voted to confirm trained surgeon and former daytime TV host Mehmet Oz as the next CMS administrator, as a major reshaping of the federal healthcare agencies continues.

At least three biotech companies say they’ve received orders to stop their work related to a Biden administration initiative to advance new Covid-19 vaccines.

AstraZeneca CEO Pascal Soriot called on Europe to step up investments and “protect its health sovereignty

Vaxart said a stop-work order has been lifted on its next-generation Covid-19 vaccine efforts planned under a Biden-era initiative, allowing it to screen participants for a large mid-stage trial to test its oral vaccine candidate.

The FDA is still reviewing a label expansion for GSK’s respiratory drug Nucala in chronic obstructive pulmonary disease despite the May 7 target date for a decision, the company confirmed to Endpoints News.

ReproNovo raises $65M for trials of leflutrozole and nolasiban in reproductive health. CEO Jean Marie Duvall plans Phase 2 studies for male infertility and IVF success rates.

Hetero Labs could launch its generic sleep disorder drug as early as 2040 under a settlement deal with Axsome Therapeutics.

Rocket's gene therapy trial on hold after patient death; Lilly acquires SiteOne for up to $1B; Compass Pathways awaits Phase 3 data; Novartis wins Regulus bidding war for $1.7B