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From more than 30 target action dates in the last three months of the year, BioSpace has narrowed the list to six regulatory decisions that could have far-reaching implications for biopharma and patients.

In one of the first demonstrations of the impact of last year’s Loper Supreme Court decision on challenges to agency authority, a judge ruled that the FDA does not have authority to regulate tests developed by clinical laboratories.

By publishing complete response letters as soon as they are issued to drug sponsors, the FDA is expanding transparency in a way that, while positioned as a public health measure, also grants investors greater visibility into regulatory decisions. Experts question whether this is the agency’s proper remit.

The FDA in September issued two rejections for spinal muscular atrophy therapies—both linked to manufacturing problems—and granted approvals in Barth syndrome and for a subcutaneous version of Merck’s Keytruda that could be key to the blockbuster’s future earnings.

Naveen Kumar Amar joins the surgical robot developer as it prepares to expand globally, including in Europe and the U.S.

The device, called Biolinq Shine, is indicated for people with Type 2 diabetes who don’t depend on insulin.

On Thursday, Texas Judge Reed O’Connor threw out a Biden-era rule that would have recouped billions of dollars in overpayments to MA plans.

The request includes a call to postpone re-certification requirements for devices already certified under the medical technology regulations.

El entorno empresarial moderno está siendo transformado por la rápida adopción de tecnologías emergentes. Herramientas como la inteligencia artificial, blockchain, el internet de las cosas, la realidad aumentada y virtual, y la automatización robótica de pro …

The company was awaiting $70 million from HealthCare Royalty but missed an agreed-upon payment condition.