All FDA articles – Page 2
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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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Business
US finalises guidance on biosimilars
Regulator clarifies requirements for allowing substitution between products
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News
Telemedicine 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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Business
Emerging 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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News
As 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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Business
Pfizer 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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Business
Pharmaceuticals 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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Opinion
The projects drug companies wish they’d never started
Failures are common in drug research, but some are bigger than others
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News
Job satisfaction among US federal scientists decreases
Survey shows many researchers think staff cuts and politics interfere with their work
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Feature
From 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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Business
Drugmaker 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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News
Fears 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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Business
FDA 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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Business
Pharmaceuticals roundup 2017
Political influence has strongly shaped industry activity in the past year
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Business
Hurricane damage squeezes supply chains
Industry and government working to minimise impact of shortages of olefin feedstocks and medical products
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Business
Long 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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Business
US state passes law blocking generic drug price-gouging
Despite industry opposition, Maryland will be able to fine companies for ‘excessive and unjustified’ price increases
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Business
US probes opioid manufacturers
Attorneys general from 41 states will investigate companies over alleged fraudulent marketing and distribution of painkillers
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Business
FDA warns Pfizer subsidiary over Epipen malfunctions
Manufacturer did not fully investigate reports of patients dying after auto-injector failures
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Business
Novartis coasts towards first CAR-T approval
Unanimous recommendation for CTL019 ahead of October decision builds confidence in T-cell genetic reprogramming
