All FDA articles – Page 3
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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
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BusinessUS probes opioid manufacturers
Attorneys general from 41 states will investigate companies over alleged fraudulent marketing and distribution of painkillers
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BusinessFDA warns Pfizer subsidiary over Epipen malfunctions
Manufacturer did not fully investigate reports of patients dying after auto-injector failures
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BusinessNovartis coasts towards first CAR-T approval
Unanimous recommendation for CTL019 ahead of October decision builds confidence in T-cell genetic reprogramming
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BusinessMallinckrodt settles US opioid lawsuit
Firm will pay $35m over allegations it failed to report suspicious orders of controlled substances
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BusinessFDA approves first sickle cell drug in almost two decades
Glutamine-based drug is the first approved for children over 5
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BusinessFDA asks Endo to take pain drug off market
Request part of larger strategy to address opioid misuse in the US
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NewsLegal battles stall US biosimilars
Unclear legislation and lack of regulatory guidance means companies are turning to the courts
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OpinionDrug regulation is a burden worth bearing
Calls to break down regulatory barriers show a misunderstanding of the industry
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NewsFDA inspection data on nearly 1,000 overseas drug firms is missing
80% of US drug ingredients now come from abroad, yet challenges remain in FDA oversight of foreign drug firms
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OpinionRegulatory tightropes
When lobbying and marketing clash with scientific evidence, regulators walk a fine line
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BusinessTroubled Theranos abandons clinical testing
Seeking to salvage some value, once-admired blood analysis firm lays off 40% of staff
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BusinessFDA’s first Duchenne drug approval reveals schism
Oligonucleotide drug reaches market amid pressure from patient families and strife over ‘patient-focused drug development’ at the regulator
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NewsUS agency bans triclosan and 18 other antibacterials
The FDA has banned 19 antimicrobials in the US and given industry a year to remove them from consumer products
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BusinessFDA urges labs to test all blood donations for Zika
Agency has also given emergency authorisation to two new Zika blood tests
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BusinessJuno CAR-T trial suspended after patient deaths
Immunotherapy study restarted with amended pre-treatment protocol
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OpinionTime for better incentives to keep drug costs low
Getting outraged at drug price hikes is all very well, but we need more constructive options
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BusinessJazz Pharma buy out Celator in $1.5bn deal
Deal centres on promising leukaemia drug fast-tracked by the US Food and Drug Administration