All Drug approval articles – Page 3
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Business
Ups and downs for erectile dysfunction drugs
First new drug in a decade approved in Europe as Viagra patent expires
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Business
Two new ‘personalised’ cancer drugs approved
Suitable patients for GSK’s melanoma treatments must be identified using an accompanying genetic test
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Morning sickness drug reintroduced to US
After being withdrawn due to litigation, the drug has been approved by the FDA
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Business
Alcohol dependence pill approved in EU
Selincro tablets from Lundbeck designed to reduce consumption of alcohol
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Merck resolves Vytorin case for $688m
Investors say the company knew about Enhance trial failure but withheld information
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Business
Flu vaccine without the eggs approved
Flublok does not require flu virus or eggs for manufacture
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Business
Laropiprant recalled
Merck & Co says it is recalling Tredaptive tablets, approved in the EU for treating patients with high cholesterol
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TB drug milestone for bedaquiline
First TB drug with a new mechanism of action for 40 years wins approval
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Approval for first gene therapy drug
Glybera (alipogene tiparvovec) injections have been approved in Europe
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Teva pulls generic antidepressant
FDA rules that Budeprion XL is not equivalent to Wellbutrin XL
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Regorafenib approved in US
Stivarga tablets approved for treatment of advanced colorectal cancer
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Pineapple gel approved for burns
EU regulators approve NexoBrid gel from MediWound for removal of scab tissue
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Myelofibrosis drug approved in EU
Jakavi (ruxolitinib) tablets are for the treatment of myelofibrosis, a rare disease affecting the bone marrow
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Generic Actos approved
Mylan, Ranbaxy and Teva have won US marketing approval for their generic versions of Actos diabetes tablets
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Bapineuzunab dropped
Development for the Alzheimer’s treatment stopped after clinical tests
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New cystic fibrosis drug in EU
Ivacaftor works by helping defective proteins function more normally
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BusinessObesity drug approved in US
Qsymia from Vivus joins Belviq in a lucrative part of the pharma industry
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Business
More testing needed for ridaforolimus
Marketing approval for anti-cancer drug ridaforolimus has been held up in the US
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Business
Three pronged approach puts brakes on US breast cancer
US approval for anti-HER2 therapy Perjeta (pertuzumab) against breast cancer
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US approves new anaemia drug
US authorities have approved Omontys (peginesatide) injections for treating anaemia in dialysis patients with chronic kidney disease
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