All FDA articles – Page 3
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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
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Business
Mallinckrodt settles US opioid lawsuit
Firm will pay $35m over allegations it failed to report suspicious orders of controlled substances
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Business
FDA approves first sickle cell drug in almost two decades
Glutamine-based drug is the first approved for children over 5
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Business
FDA asks Endo to take pain drug off market
Request part of larger strategy to address opioid misuse in the US
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News
Legal battles stall US biosimilars
Unclear legislation and lack of regulatory guidance means companies are turning to the courts
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Opinion
Drug regulation is a burden worth bearing
Calls to break down regulatory barriers show a misunderstanding of the industry
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News
FDA 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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Opinion
Regulatory tightropes
When lobbying and marketing clash with scientific evidence, regulators walk a fine line
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Business
Troubled Theranos abandons clinical testing
Seeking to salvage some value, once-admired blood analysis firm lays off 40% of staff
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Business
FDA’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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News
US 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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Business
FDA urges labs to test all blood donations for Zika
Agency has also given emergency authorisation to two new Zika blood tests