Browsing Tag:drug

biogen-alzheimers-drug-and-the-new-battle-over-dementia-treatment
Aduhelm from BiogenSource: BiogenThe FDA approval of Biogen's Alzheimer's drug Aduhelm marked a milestone in Dr. Paul Aisen. The director of the Alzheimer's Therapeutic Research Institute at USC has focused on the treatment of neurodegenerative disease for the past three decades and in recent years has helped guide this particular drug through the various phases of clinical...
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three-f-d-a-advisers-resign-over-agencys-approval-of-alzheimers-drug
In a marked disagreement over the Food and Drug Administration's approval of Biogen's controversial Alzheimer's drug earlier this week, three scientists stepped down from the independent committee that advised the agency on the treatment."This could be the worst regulatory decision the FDA has made that I can remember," said Dr. Aaron Kesselheim, professor of medicine at Harvard Medical...
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alzheimers-drug-is-bonanza-for-biogen-most-likely-at-taxpayer-expense
In addition to the US, Biogen has also asked regulators in Australia, Brazil, Canada, the European Union, Japan, and Switzerland to review the drug.US approval is a critical win for a company that has relied on Aduhelm to offset stalled or declining sales of its other products. Competitors introduced generics of Biogen's multiple sclerosis drug Tecfidera last year,...
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f-d-a-approves-alzheimers-drug-despite-fierce-debate-over-whether-it-works
Die Food and Drug Administration hat am Montag das erste neue Medikament gegen die Alzheimer-Krankheit seit fast zwei Jahrzehnten genehmigt, eine umstrittene Entscheidung, die trotz des Widerstands des unabhängigen Beratungsausschusses der Agentur und einiger Alzheimer-Experten getroffen wurde, die sagten, es gebe nicht genügend Beweise dafür, dass das Medikament Patienten helfen kann .Das Medikament Aducanumab, das unter dem Markennamen Aduhelm...
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biogens-alzheimers-drug-approved-by-fda-first-new-therapy-in-nearly-two-decades
The Food and Drug Administration approved Biogen's Alzheimer's drug aducanumab on Monday, making it the first U.S. regulator-approved drug to slow cognitive decline in people with Alzheimer's and the first new drug for the disease in nearly two decades.The FDA's decision was eagerly awaited. The drug, which is marketed under the name Aduhelm, is also expected to generate...
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f-d-a-approves-new-drug-to-treat-vaginal-yeast-infections
The Food and Drug Administration on Tuesday approved a new drug to treat a vaginal yeast infection, which is particularly common in pregnant women who take birth control pills or take antibiotics.The drug Brexafemme (Ibrexafungerp) manufactured by SCYNEXIS is a one-day oral treatment and the first in a new class of triterpenoid antifungal drugs. The company said the...
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kentucky-derby-winner-medina-spirit-fails-second-drug-test
Kentucky Derby winner Medina Spirit's second blood test confirmed the presence of the banned steroid betamethasone, an attorney for the horse owner told CNBC on Wednesday.The second positive test increases the likelihood that Medina Spirit's victory on May 1 will be overturned by Kentucky race officials and Mandaloun, who finished second that day, will be declared the winner.Hours after...
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