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News Topic - FDA

RSS feedDisplaying articles 1 - 10 of most recent articles

Photo from Mail Online
FDA approved Alzheimer's drug because trial data showed it was 'reasonably likely' to help patients The FDA said this week that they stand by their controversial approval of aducanumab. The drug, which many doubt even works, will cost $59,000 a year for consumers and cost Medicare $29 billion.
Mail Online | 3 hours, 2 minutes ago | comment? | recommend
Eisai And Biogen Inc. Announce U.S. FDA Grants Breakthrough Therapy Designation For Lecanemab (BAN2401), An Anti-Amyloid Beta Protofibril Antibody For TOKYO and CAMBRIDGE, Mass., June 23, 2021 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") today announced th
PR Newswire | 3 hours, 40 minutes ago | comment? | recommend
Photo from Politico
FDA to add warning about rare heart inflammation to Moderna, Pfizer vaccine fact sheets A CDC safety panel has determined there is a "likely association" between the Pfizer and Moderna shots and cases of myocarditis and pericarditis in vaccine recipients.
Politico | 4 hours, 7 minutes ago | comment? | recommend
Photo from Wired News
Google Launches a New Medical AppOutside the US The dermatology AI app won approval for use in the EU but not with the FDA, an odd twist on Europe's reputation for tough rules on tech.
Wired News | 11 hours, 46 minutes ago | comment? | recommend
This Leading Healthcare Company's New Obesity Treatment Has Great Potential A new FDA-approved product with the potential to triple weight loss in obesity patients should be a huge win for the company. | 11 hours, 56 minutes ago | comment? | recommend
Photo from PR Newswire
Over a year into the global pandemic, Samsung Biologics continues to leverage innovative virtual platform for remote audits and regulatory inspections Samsung Biologics' Live Virtual Tour (LVT) used in one of the earliest FDA full virtual assessments Recently hosted EMA for 6 PAIs simultaneously using LVT INCHEON, South Korea, June 23, 2021 /PRNewswire/ -- Samsung Biologics, a global contract developmen
PR Newswire | 12 hours, 18 minutes ago | comment? | recommend
Is ChemoCentryx a Buy? Next month is sure to be a big one for the company, with the FDA slated to make a decision on its most advanced drug, avacopan. | 12 hours, 28 minutes ago | comment? | recommend
Photo from USA Today
Behind the historic US vaccine effort is FDA's Peter Marks. The job is 'not for the faint of heart.' The FDA's Dr. Peter Marks has played a key role in nearly every major vaccine-related decision since the United States'COVID-19 outbreak began.
USA Today | 13 hours, 45 minutes ago | comment? | recommend
Photo from Politico
FDA approved Alzheimer's drug over internal objections FDA gave the drug conditional approval earlier this month, making it the first new Alzheimers therapy approved in nearly 20 years.
Politico | Jun 22, 2021 10:52 PM [GMT] | comment? | recommend
Photo from New York Post
FDA approved controversial Alzheimers drug despite objections from staff The Food and Drug Administration gave the green light to a controversial new Alzheimers drug -- despite objections from some of its own experts, according to internal memos.
New York Post | Jun 22, 2021 10:07 PM [GMT] | comment? | recommend article from New York, New York