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
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.
Lilly's Mounjaro does not need separate indication for sleep apnea, EMA panel determines
An expert panel of the EU drug regulator, the European Medicines Agency (EMA), has determined that Eli Lilly's (NYSE:LLY) weight-loss drug Mounjaro (tirzepatide) does not need a separate indication for the treatment of obstructive sleep apnea (OSA).
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,
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?
FiercePharma2d
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 ...
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 ...
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 ...
Medscape2d
EMA Supports Expanding Use of Ofev to Pediatric ILDs
Europe’s medicines regulator has backed a pediatric indication for Ofev to treat progressive fibrosing interstitial lung ...
Merck & Co. Gets Key European Backing for Welireg in Two Uses
Merck & Co. said a key European regulatory committee has recommended conditional approval of its Welireg oral cancer drug in a pair of indications.
Novo Nordisk's Ozempic Label Expansion Snags Approval From European Drug Regulator's Advisory Panel
Novo Nordisk's Ozempic gains positive EMA opinion for label update after FLOW trial data show significant kidney and ...
Medscape2d
Rytelo Recommended in Europe for Myelodysplastic Syndromes
The European Medicines Agency (EMA) has given a positive recommendation for Rytelo ( imetelstat) for the treatment of adult ...
MarketWatch2d
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 ...
Roche Vabysmo PFS approved in EU for three retinal conditions
Roche (RHHBY) announced that the European Medicines Agency, EMA, has approved Vabysmo 6.0 mg single-dose prefilled syringe, PFS, for use in the ...
Medscape2d
EMA Recommends Seladelpar for Primary Biliary Cholangitis
The EMA’s Committee for Medicinal Products for Human Use (CHMP) determined that expected clinical benefits of seladelpar include delayed development of liver fibrosis and cirrhosis, potentially ...