News

BeOne gets FDA nod for tablet version of zanubrutinib
BeOne Medicines (NASDAQ:ONC) gains FDA approval for a new tablet version of Brukinsa, simplifying dosage for patients.
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 ...
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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 ...
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FDA Approves Brukinsa Tablet For Various Blood Cancers
FDA approves new Brukinsa tablet for five blood cancers, offering simpler dosing with the same safety and effectiveness as ...
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, ...
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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 ...
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 ...