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AZ claims EU approval for new Calquence regimens in CLL
AstraZeneca has secured a key approval for its BTK inhibitor Calquence in Europe, currently facing a strong challenge from BeOne's rival Brukinsa.
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Wockhardt has high hopes for novel antibiotic Zaynich
Wockhardt has completed a pre-filing meeting with the FDA and is preparing to submit its novel antibiotic Zaynich in the US and Europe.
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NHS cleared to use Novo Nordisk's long-acting growth hormone
Novo Nordisk's long-acting injectable Sogroya has been backed for NHS use in young people with growth hormone deficiency.
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Ascletis says oral acne drug shows "exceptional efficacy"
Phase 3 results for Ascletis' novel acne candidate have set up filings in China and bode well for a similar drug being developed by Sagimet in the US.
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Amid staff cuts, FDA looks to AI to 'optimise' reviews
The FDA has rolled out its highly-touted generative AI tool, almost a month early, with a promise to reduce the time taken for regulatory reviews.
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