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Science|Business1h
EU pharmaceutical reform negotiations to kick off, but concerns remain
The first trilogue negotiations between EU lawmakers over the long-awaited reform to Europe’s pharmaceutical legislation will ...
Healthy Returns: Ozempic, Wegovy linked to rare cases of serious eye condition
Novo Nordisk’s drugs are being linked to an eye condition that can cause vision loss, while health tech companies made CNBC’s ...
BeOne gets FDA nod for tablet version of zanubrutinib
BeOne Medicines (NASDAQ:ONC) said on Wednesday that it has received approval from the U.S. FDA for a new tablet version of ...
Open Access Government2h
Oxford’s Nipah virus vaccine wins EMA PRIME status in UK first
The University of Oxford has received support from European Medicines Agency's (EMA) for its vaccine targeting the deadly ...
EU Drug Regulator Finds ‘Very Rare’ Ozempic Link to Vision Loss
Patients taking weight-loss medicines such as Novo Nordisk A/S’s Ozempic and Wegovy are at risk of developing an eye ...
Tempest Receives Orphan Drug Designation from the European Medicines Agency for Amezalpat for the Treatment of Patients with HCC
EMA Orphan Drug Designation (ODD) builds on U.S. Food & Drug Administration (FDA) ODD and Fast Track Designation, ...
BioSpace5d
EU Regulators Confirm Rare Vision Loss Risk for Novo’s Semaglutide
Given the evidence, the committee has recommended that the labels for Novo Nordisk’s Wegovy and Ozempic be updated to include ...
Medical Dialogues2d
Diabetes and Weight-Loss Drug Semaglutide Linked to Rare Eye Condition: European Medical Agency
Pharmacovigilance Risk Assessment Committee (PRAC) has concluded its review of semaglutide-containing medicines, confirming a ...
Novo Nordisk's Wegovy Tied To Increased Risk Of Rare Vision-Loss Disorder, European Regulators Say
The European Medicines Agency's (EMA) safety committee (PRAC) has concluded its review of medicines containing semaglutide ...