Novartis said the Committee for Medicinal Products for Human Use approved a label update for Cosentyx (secukinumab), the first interleukin-17A approved to treat psoriasis.
The U.S. Food and Drug Administration delayed indefinitely implementation of a new nutrition facts label that would enlarge calorie counts, itemize added sugar and bring serving sizes in line with actual average portions.
Johnson & Johnson’s type 2 diabetes drug Invokana significantly reduced the risk of serious heart problems in patients with established heart disease or at elevated risk in a pair of large studies, according to data presented at a medical meeting.
Johnson & Johnson is required to add new warnings to its diabetes drug Invokana about the risk of foot and leg amputations, the U.S. Food and Drug Administration said.
The FDA declined an application to include labeling info for Merck’s Januvia and Janumet that the diabetes drugs do not raise the risk of major heart problems.
The prescribing label for Biogen’s big-selling oral multiple sclerosis drug Tecfidera has been updated to include a warning of potential liver injury.
The U.S. health regulator issued draft guidance, recommending ways to communicate promotional materials and additional information that is not on the label of medical products.
The European Medicines Agency warned for the second time in 2016 that some of the top-selling hepatitis C treatments could reactivate hepatitis B in patients.
Lipocine Inc. said its oral testosterone replacement product did not get the approval in the United States, sending the drugmaker’s shares down 52 percent in premarket trading.
An FDA advisory panel will be asked to vote on whether a diabetes drug made by Eli Lilly and Boehringer Ingelheim cuts the risk of cardiovascular death, according to the agency’s website.