All Drug approval articles
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BusinessUS regulator says phenylephrine is ineffective as a decongestant
FDA will begin consultation on removing the drug from hundreds of over-the-counter remedies
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BusinessAntibodies face Alzheimer’s reality
Companies are convincing regulators, but will doctors use them, and will providers pay for them?
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OpinionRegulators must follow their heads, not their hearts
The 2019 US approval of antibiotic Recarbrio seems not to have met the normally expected standards
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WebinarHow to profit from recent innovations in small molecule drug discovery
Reduce risk, cost and wasted time in the new era of small molecule drug discovery
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NewsRush to approve Covid vaccine prompted by politics may end in disaster
Push by governments to pass a vaccine without appropriate evidence could damage fight against virus
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BusinessCancer and rare diseases dominated 2019 drug approvals
More streamlined review processes and changing R&D priorities have contributed to sustained increase in new medicines
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ArticleHow biologics have changed the rules for pharma
The impact of the latest generation of drugs for the healthcare industry
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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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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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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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OpinionHow safe should drugs be?
What does spotting new risks in approved medicines say about how effective regulators are?
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BusinessChina approves BMS’s hepatitis C drugs
Combination is first all-oral treatment in China, where Gilead’s Sovaldi is not yet approved
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BusinessEU recommends withdrawing drugs approved on unreliable data
Indian firm Micro Therapeutic Research Labs accused of misrepresenting clinical data and documentation deficiencies
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NewsPfizer launches new biosimilar drug in US
Autoimmune disease treatment becomes only the second biosimilar to be approved by the FDA
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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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Business
Merck & Co joins hepatitis C party
New drug adds new treatment options and increases competition in premium market
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BusinessViral cancer therapy approved in the US
T-Vec is the first approved oncolytic virus, but its limited treatment scope means it is unlikely to become a blockbuster
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Business
FDA takes action to remove biosimilars roadblock
The US Food and Drug Administration proposes system to name biosimilar drugs
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BusinessFemale sexual desire drug approved
Concerns raised over efficacy, side effects and use of advocacy campaigning to influence regulatory decisions
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Business
US approves biosimilar filgrastim
Sandoz’s version of Amgen’s Neupogen is ‘biosimilar’ but not ‘interchangeable’