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Since its inception in 1992, the FDA’s accelerated approval pathway has helped shepherd nearly 300 new drugs to the market. However, recent years have seen a number of high-profile market withdrawals and failed confirmatory trials.

The Department of Internal Medicine is pleased to welcome the following new staff, faculty, postdoctoral fellows, and postdoctoral associates who joined the team in August 2024:

A landmark Supreme Court decision that reins in federal agencies’ authority is expected to hold dramatic consequences for the nation’s health care system, calling into question government rules on anything from consumer protections for patients to drug safety to nursing home care. YSPH Professor Dr. Joseph Ross provides insight.

Drugs for serious or life-threatening diseases can receive expedited U.S. Food and Drug Administration (FDA) review, allowing patients to receive faster access to promising new treatments. Under the expedited review pathway of accelerated approval, drugs can be FDA-approved based on surrogate markers or proxy measures such as changes in imaging or lab tests that are “reasonably likely” to predict whether patients improve in how they feel, function, or survive.

Researchers are calling on the US Food and Drug Administration (FDA) to be more transparent in how it incorporates recommendations from independent scientists on its advisory panels when it approves drugs or makes other key decisions.

Surrogate markers of disease outcome aimed at speeding clinical trials are routinely accepted by the FDA for drug approvals, but most lack the requisite evidence.

Researchers estimated the costs to produce a range of diabetes medicines, including insulin, SGLT2 inhibitors, and GLP-1 agonists. Their findings highlight market prices that are far above those costs.

A recent study published in Journal of the American Medical Association (JAMA) Network Open found that key diabetes medicines can likely be manufactured at costs far below their current market prices. The economic evaluation, led by Yale postdoctoral associate Melissa Barber, PhD in conjunction with collaborators from Doctors Without Borders (Médecins Sans Frontières (MSF)), calculated the manufacturing costs for insulins, sodium-glucose cotransporter 2 inhibitors (SGLT2Is), and glucagon-like peptide 1 agonists (GLP1As) – all widely used diabetes medicines.

A recent collaborative study conducted by Yale researchers sought to apply these methods towards developing a framework for measuring equitable readmissions to the hospital, and to identify hospitals that have equitable rates of readmission.