With Biogen gaining FDA approval for its Alzheimer’s drug, aducanumab, questions have started to swirl around how health insurers will cover the $56,000-a-year treatment. 1. The FDA approved Biogen’s ...
On Monday, the US Food and Drug Administration granted approval to a keenly-watched Alzheimer’s drug, aducanumab, developed by the drugmaker Biogen. The decision to approve the drug, which was once ...
A report from the U.S. FDA's Office of Inspector General is calling into question the thoroughness of the agency's accelerated approval process, and is using treatments from Sarepta Therapeutics ...
At its November meeting, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) voted against Biogen's controversial Alzheimer's drug aducanumab (Aduhelm), ...
WASHINGTON - Government health officials on Monday approved the first new drug for Alzheimer’s disease in nearly 20 years, disregarding warnings from independent advisers that the much-debated ...
CAMBRIDGE, Mass. -- Biogen Inc. said Tuesday it will seek federal approval for a medicine to treat early Alzheimer's disease, a landmark step toward finding a treatment that can alter the course of ...
CAMBRIDGE, Mass., Oct. 19, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) will present new data from its Alzheimer’s disease portfolio at the upcoming Clinical Trials on Alzheimer’s Disease (CTAD ...
The FDA needs to strengthen guardrails to ensure its accelerated approval pathway is used appropriately, the HHS Office of Inspector General (OIG) said. The agency should do two things, the OIG ...
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