All FDA articles – Page 3
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OpinionWill Novartis's data manipulation damage relations with regulators?
Trust between the two has been compromised
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NewsData manipulation casts shadows on Novartis gene therapy
Manufacturing problems with other new medicines highlight difficulty of developing advanced treatments
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OpinionIs this a golden age of new drug classes?
A host of new treatment modes are hitting the clinic and the market
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BusinessUS finalises guidance on biosimilars
Regulator clarifies requirements for allowing substitution between products
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NewsTelemedicine abortion provider locks horns with US drug regulator
Food and Drug Administration urged to take action against abortion charity by US politicians
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BusinessEmerging from the US opioid crisis
With litigation against suppliers in full swing, how does the US counter its addiction to powerful painkillers?
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NewsAs government shutdown drags on US researchers find themselves caught in the crossfire
As the shutdown enters its second month many scientists have been left struggling to pay the rent or childcare as research projects flounder
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BusinessPfizer to close two manufacturing plants in India
Closures will lead to the loss of 1700 jobs – almost 6% of the pharma giant’s manufacturing workforce
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BusinessPharmaceuticals roundup 2018
Merger deals, product approvals and infrastructure changes have been overshadowed by political uncertainty, in Europe and around the world
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OpinionThe projects drug companies wish they’d never started
Failures are common in drug research, but some are bigger than others
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NewsJob satisfaction among US federal scientists decreases
Survey shows many researchers think staff cuts and politics interfere with their work
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FeatureFrom folklore to pharmacy
Although many drugs have in the past come from plants, Hayley Bennett discovers that it’s hard work getting them approved today
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BusinessDrugmaker blocks Nevada execution
Alvogen obtains a restraining order to delay US prisoner’s execution, saying Nevada state obtained its sedative midazolam via ‘subterfuge’
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NewsFears that US 'right to try' law could put patients at risk
Legislation will give terminally ill patients the option of taking medicines that have had little testing
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BusinessFDA new drug approvals more than doubled in 2017
The FDA approved 46 new drugs last year – the highest number in over two decades – due to factors like streamlined policies at the agency
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BusinessPharmaceuticals roundup 2017
Political influence has strongly shaped industry activity in the past year
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BusinessHurricane damage squeezes supply chains
Industry and government working to minimise impact of shortages of olefin feedstocks and medical products
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BusinessLong road to recovery for Puerto Rico pharmaceuticals
As inhabitants begin to rebuild their lives after the devastation of hurricane Maria, the island’s drug manufacturers are recovering slowly
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BusinessUS state passes law blocking generic drug price-gouging
Despite industry opposition, Maryland will be able to fine companies for ‘excessive and unjustified’ price increases