All Drug approval articles – Page 2
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BusinessUS opens up home DNA screening
FDA approves single disease genetic test and clears pathway for similar devices
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Business
Europe approves stem cell therapy
Treatment for burn-damaged eyes uses patient’s own scaffold-grown cells
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Business
US approves internal tissue glue
Urethane-based TissuGlu aids healing after abdominal surgery
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BusinessUS poised to approve its first ‘biosimilar’ drug
FDA panel recommends Sandoz’s copy of Amgen’s Neupogen
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Business
EU recommends Parkinson’s drug for approval
First new molecule for a decade, but Alzheimer’s still posing challenges as antibody treatment withdrawn from trials
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Business
Ranbaxy sues over withdrawn US approvals
Company says decision is ‘unconstitutional’ and deprives it of hundreds of millions of dollars in revenue
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Business
Review says cheaper drug is safe for eye disease
Cochrane collaboration says side effects of expensive Lucentis and off-label Avastin are similar
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Business
Cipla targets asthma market with Advair copy
Indian pharma company Cipla has launched a generic version of GSK’s best selling drug
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Business
China struggles to speed up drug reviews
Regulator considers outsourcing reviews, and creates a fast-track scheme for priority generics
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Business
First of a new breed of anticancer antibodies approved in Japan
Ono claims Opdivo is the first anti-PD1 treatment in the world
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Business
Inhaled insulin approved in US
European committee recommends approval for generic long-acting insulin
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Business
Drug companies rapped for anticompetitive behaviour
Italian authorities demand €1.2 billion in damages from Roche, Novartis and Pfizer
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BusinessNew wave of hepatitis C drugs hits US shore
J&J’s once-daily drug approved by FDA, but rivals are hot on its heels
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BusinessNew respiratory drugs neck and neck
Combination inhalers from GSK and Novartis approved in EU and Japan
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Business
First biosimilar antibody drugs approved in Europe
European commission gives final approval to generic infliximab copies
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Business
Nice rules against Afinitor
Novartis’ drug will not routinely be available on the UK health service
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News
Chinese drug watchdog set for major reforms
Measures will speed up drug approvals and decentralise controls on generics
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NewsIndian U-turn on diabetes drug ban
Suspension of cheap and popular medicine reversed but will now come with new safety warnings
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Business
Biosimilar drugs step up complexity
First generic monoclonal antibodies recommended for approval in Europe
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