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Justice Department antitrust enforcers are reportedly preparing to approve two health care industry mergers: CVS Health's acquisition of Aetna and Cigna's purchase of Express Scripts. Both deals could receive formal antitrust approval as soon as the next few weeks, according to people familiar with the matter.

In a Texas courtroom on Wednesday, a group of Republican attorneys general is set to face off against a group of Democratic attorneys general in a lawsuit aimed at striking down the Affordable Care Act.

Agency explains risk, details its ongoing investigation

UCSF’s Gibson, Remington Honor Medalist, was leader for diversity and mentor to many

Legislation creating a nationwide Prescription Safety Alert System, designed to better protect patients at risk of opioid overuse, was introduced in the House of Representatives on August 30.

In a statement, FDA Commissioner Scott Gottlieb, MD, and Janet Woodcock, MD, director of FDA's Center for Drug Evaluation and Research (CDER), provide an update on the agency's investigation into an impurity, NDMA, found in some generic versions of the blood pressure medication valsartan.

Separate guidelines issued for patients with acute and chronic pain

FDA Commissioner Scott Gottlieb says the agency's efforts to address the opioid crisis cut across three broad areas. "First, we set out to cut the rate of new addiction. We did this in part by taking new steps to rationalize the prescribing of opioids, and amounts dispensed, as a way to reduce exposure to the drugs in the medical setting.

Investigators used FDA summaries to characterize the randomized clinical trials that regulators draw on when considering approval of cardiovascular devices. As applications move through the agency's Priority Review program, however, the quality of that underlying evidence is not known. JAMA Internal Medicine editor Rita F.

DIR fees are now drawing attention outside the pharmacy world