approvals
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Merck expands HIV portfolio with FDA approval of Idvynso single-tablet regimen
The tablet combines 100 mg of doravirine and 0.25 mg of islatravir in a once-daily formulation.
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European Commission approves Merck’s Enflonsia for RSV prevention in infants
The approval grants the pharmaceutical giant the right to market Enflonsia across all 27 member states of the European Union, as well as Iceland, Liechtenstein, and Norway.
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FDA clears Prodeon Medical’s Urocross expander for non-permanent BPH Treatment
GlobalData analysis projects that the global nephrology and urology device market, which includes BPH treatments, will reach almost USD12 billion in 2035, up from around USD8.6 billion in 2024.
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Roche obtains CE mark for first blood-based ApoE4 Alzheimer’s test
Alzheimer’s disease drives up to 70% of dementia cases worldwide, presenting healthcare systems with mounting challenges.
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Moderna’s combination Covid-Flu vaccine clears key European regulatory hurdle
The EMA will now proceed with a final decision, potentially clearing the way for global distribution of this combination immunization.
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Mubadala Bio’s subsidiary secures prestigious EU Quality certification
EU GMP certification confirms that Bioventure Healthcare meets the European Union’s demanding requirements for pharmaceutical manufacturing.