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FDA has approved cemiplimab-rwlc (Libtayo—Regeneron Pharmaceuticals) injection for the treatment of individuals with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not eligible for curative surgery or curative radiation. This is the first FDA approval of a drug specifically for advanced CSCC.

Study finds that despite warnings, the ubiquitous drug is being misused

As the 2018–19 influenza season officially gets under way, FDA has issued an update about its preparations for the influenza season and stressed the continued importance of getting vaccinated.

Preliminary data indicate that influenza and its complications took the lives of an estimated 80,000 Americans last winter. CDC director Robert Redfield announced the total in an interview this week. "I'd like to see more people get vaccinated," Redfield said.

FDA is considering banning online e-cigarette sales, Commissioner Scott Gottlieb said Tuesday. It's "on the table" and is something the agency is "very clearly looking at it," Gottlieb said in Washington during a panel discussion on vaping hosted by Axios.

Even though 12 have been approved, what’s the reality for biosimilars in the U.S.?

A large clinical trial found that the drug icosapent ethyl (Vascepa—Amarin Pharms) dramatically reduced the rate of cardiovascular events in people with a history of heart disease or Type 2 diabetes, according to early results that were announced on Monday. The findings were particularly relevant for people with high triglycerides.

AstraZeneca's diabetes drug dapagliflozin (Farxiga) met a key goal in a major clinical study designed to show its heart-protecting benefits in a wide range of patients. The cardiovascular (CV) profile of medicines to treat diabetes is an important focus for doctors and patients.