“All of the FDA 510K approvals can be searched online. This is a big day for theranos,” says ElHosseiny. “Our goal is to bring advanced diagnostic technology to the public in a safe, transparent way.

The agency will allow BMS to discontinue REMS programs for both therapies and reduce certain patient monitoring requirements.

June brought major prostate cancer updates, and CURE is sharing the latest FDA approvals, label expansions, and emerging data ...

Bristol Myers (BMY) receives FDA approval for label updates for Breyanzi and Abecma, that can ease access to the cancer cell ...

Vital chemotherapy drugs used around the world have failed quality tests, putting cancer patients in more than 100 countries ...

Label updates have been approved by the FDA for the CAR T-cell therapies Breyanzi and Abecma in large B cell lymphoma and ...

The Breyanzi REMS program and the Abecma REMS program were established due to the risk of cytokine release syndrome and neurologic toxicities.

FDA approved label changes for Breyanzi and Abecma, easing access by reducing monitoring rules and eliminating REMS safety ...

In a breakthrough for incretin medicines, China’s National Medical Products Administration (NMPA) has approved Innovent’s ...

The FDA has approved expanded use of GE HealthCare’s PET imaging agent, Vizamyl, for improved detection and monitoring of Alzheimer’s disease. The updated label now allows Vizamyl to be used to detect ...

B ristol Myers Squibb (BMS) has announced that the US Food and Drug Administration (FDA) has given approval to label updates ...