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Buried deep in the administration’s budget proposal are a series of drug price control measures that could rattle the pharmaceutical industry. Read More
The full Senate is scheduled to decide on Feb. 22 whether Robert Califf should be the next FDA commissioner, after Majority Leader Sen. Mitch McConnell (R-Ky.) scheduled a cloture vote late Thursday. Read More
A California supplement maker is in hot water after being accused of making drug-like claims about its products and relying on improper production methods. Read More
Following a safety review, the FDA has added additional warnings to the labels of SGLT2 inhibitors for diabetes because they can cause the body to produce too much acid in the blood or lead to serious urinary tract infections. Read More
European officials are pushing for greater synchronicity between the U.S. and EU regulators on generic approval processes as part of broader trade negotiations. Read More
The European Medicines Agency has accepted Sandoz’s MAA for its biosimilar to Amgen’s Neulesta to help the body make white blood cells after receiving cancer medications. Read More