All Drug approval articles
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BusinessUS approves pancreatic cancer treatment that targets ‘undruggable’ proteins
Daraxonrasib success offers hope of further approvals for Ras-inhibitor drug candidates targeting various cancers
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BusinessProtein degrader approval offers hope to relapsed multiple myeloma patients
Highly potent molecular glue drug iberdomide doubles the number of patients reaching fewer than one myeloma cell per 100,000 in bone marrow
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BusinessOral cholesterol-lowering peptide approved after a decade in development
Merck & Co’s Lipfendra (enlicitide) employs 13 enzymes in biocatalytic synthesis
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BusinessRegulators push Amgen to withdraw drug due to data manipulation
Questions raised over safety and efficacy of Tavneos (avacopan)
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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