european medicines agency news

EU, Lilly and Mounjaro

EU drugs regulator backs Mounjaro's sleep apnea use without fresh approval for Lilly

The European Medicines Agency has allowed Eli Lilly to update the product label of its weight-loss drug Mounjaro to show it has benefit in treating a sleep disorder without approving it specifically for the disease,

Bloomberg on MSN · 1d

Eli Lilly’s Mounjaro Won’t Have Separate Sleep Apnea Label in EU

Eli Lilly & Co.’s weight-loss and diabetes drug Mounjaro won’t be reclassified as a sleep apnea treatment in Europe, with regulators saying Friday that use of the drug is already covered in its approval as a weight-loss medicine.

Seeking Alpha on MSN · 1d

Lilly's Mounjaro does not need separate indication for sleep apnea, EMA panel determines

Stock Editorial via Getty Images An expert panel of the EU drug regulator, the European Medicines Agency (EMA), has determined that

Reuters on MSN · 1d

EMA says Lilly's weight-loss drug does not need separate approval for sleep apnea

The European Medicines Agency said on Friday Eli Lilly's weight-loss drug Mounjaro does not need a separate approval for the treatment of a sleep disorder called obstructive sleep apnea (OSA). The hea

Hosted on MSN · 1d

Eli Lilly to test weight loss drug Zepbound to treat addiction

Weight loss injections have become a popular choice to help people curb their appetite, but can they curb addiction, as well?

2don MSN

European drug regulator allows Novo to include reduction of kidney disease in Ozempic label

The European Medicines Agency (EMA) will allow Novo Nordisk to add risk reduction for events related to kidney disease to the ...

FiercePharma1d

EMA backs Merck’s Welireg, Bayer’s ATTR med and Gilead’s liver drug from $4.3B deal

Merck & Co.’s kidney cancer drug Welireg, Bayer and BridgeBio’s transthyretin amyloid cardiomyopathy (ATTR-CM) therapy, and ...

Bayer Gets EU Backing for Heart Drug, Easing Patent Concerns

Bayer AG won the backing of European Union regulators for its cardiology drug as the German company fights to offset the ...

1don MSN

Antidepressant Recall Update As FDA Sets Risk Level

233,003 bottles of duloxetine have been recalled due to potentially containing high levels of cancer-causing impurities.

Novo Nordisk's Ozempic set to include kidney treatment label in EU

Novo Nordisk announced on Thursday that a key European Medicines Agency committee has backed a label update for weight-loss ...

Medscape1d

The European Medicines Agency (EMA) has given a positive recommendation for Rytelo ( imetelstat) for the treatment of adult ...

MarketWatch1d

Gilead Gets Key European Backing for Liver-Disease Treatment

The biopharmaceutical company Friday said the recommendation by the European Medicines Agency's Committee for Medicinal Products for Human Use covers seladelpar in combination with ...

Europe allows Novo to include reduction of kidney disease in Ozempic label

The European Medicines Agency (EMA) will allow Novo Nordisk to add risk reduction for events related to kidney disease to the ...

Medscape1d

Allan-Herndon-Dudley syndrome is caused by mutations in the gene coding for a thyroid hormone transporter, preventing thyroid ...

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