Market Access News | pharmaphorum

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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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Stealth BioTherapeutics' chief executive Reenie McCarthy

Axe falls on Stealth Bio staff after FDA rejects lead drug

Stealth BioTherapeutics' filing for Barth syndrome therapy elamipretide has been turned down by the FDA, but there may be a way forward for the drug.

AZ claims EU approval for new Calquence regimens in CLL

Wockhardt has high hopes for novel antibiotic Zaynich

NHS cleared to use Novo Nordisk's long-acting growth hormone

Ascletis says oral acne drug shows "exceptional efficacy"

Amid staff cuts, FDA looks to AI to 'optimise' reviews

Axe falls on Stealth Bio staff after FDA rejects lead drug

LSX2026: On promise and patience, with Hans Schambye

Using AI-driven synthetic personas to take your insights fur...

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