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An industry source said “most, if not all” of the people at CDRH who were recently dismissed are now being asked to return.

The health IT vendor was delisted from trading on Nasdaq last year for failing to file timely financial reports. Last month, the company ended a strategic review without finding a buyer.

Pemgarda has a standing emergency use authorization as a prophylaxis for immunocompromised patients, but FDA’s stringent requirements for antibody activity boxed out its potential use as a post-exposure treatment.

The treatment, called DB-OTO, is one of several early-stage gene therapies being developed to treat relatively straight-forward causes of genetic deafness.

The brain-computer interface technology personalizes therapy based on an individual’s brain activity.

The “Big Three” PBMs are kicking their suit up to the 8th Circuit and, in the meantime, are once again asking a Missouri district judge to halt the FTC’s administrative case against them.

The lawsuit claims Natera aggressively recruited bioinformatics scientists from Guardant to “jumpstart its lagging position in the early cancer test industry.”

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Investment could rise in 2025 if interest rates decline and the Trump administration is friendly to private equity firms.

President Trump also refused to promise pharma execs that he would hamstring the IRA’s drug negotiation program.