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Novo Nordisk, European Medicines Agency
EU Drug Regulator to Review Ozempic’s Possible Link to Eye Condition
The studies didn’t demonstrate a causal relationship between semaglutide—the ingredient used in both Ozempic and Wegovy—and the condition, the Danish drugmaker said.The company’s internal safety assessment and evaluation of the research studies determined that the benefit-risk profile of semaglutide remains unchanged,
Novo Nordisk's Ozempic faces EU review for potential eye disease connection
The European Union's drug regulator said it would assess two new Danish studies that link Novo Nordisk's popular diabetes drug Ozempic to a rare eye disease.
EMA to Investigate Eye Risk for Novo’s Ozempic: Reuters
Following an appeal by the Danish Medicines Agency, the European Union’s drug regulator will review two new studies that have strengthened the link between Novo Nordisk’s blockbuster GLP-1 and a rare eye disease.
Novo Nordisk's Ozempic potentially investigated for rare eye condition
Denmark's drug regulator has asked the European Medicine Agency's safety committee to evaluate two studies that found a potential link between Novo Nordisk's (NVO) type 2 diabetes drug Ozempic (semaglutide) and a rare eye condition.
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How are emerging plasma biomarkers related to the diagnostic tests currently used in clinical routines? And does the earlier ...
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Omeros Reports Narsoplimab TA-TMA Trial Success; Stock Surges
Omeros reports that narsoplimab has not raised any notable safety issues across all clinical studies. For the treatment of TA ...
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on MSN
Nanoliposomes pave way for treatment of rare genetic disorder
An international research team has developed a new therapy based on nanotechnology called nanoGLA for the treatment of Fabry ...
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on MSN
GSK’s Cancer Drug Jemperli Moves a Step Closer to European Marketing Permission
In one of the final steps before a marketing authorization decision by the European Medicines Agency, it recommended ...
Medscape
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Infants Exposed to Minoxidil May Develop Hypertrichosis
During an interview with the family, it was revealed that the infant’s father had been using 5% topical minoxidil to treat ...
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Danish agency seeks probe as Ozempic study shows link to vision loss
The Danish Medicines Agency said it would ask European authorities to review two new studies that point to a link between ...
PharmiWeb
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Johnson & Johnson submits application to the European Medicines Agency seeking approval of a new indication for IMBRUVICA® (ibrutinib)
The European MCL Network Phase 3 TRIANGLE study, evaluated ibrutinib in combination with induction immunochemotherapy, both with and without an autologous stem cell transplant, followed by 24 months f ...
FiercePharma
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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 ...
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Ozempic
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