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RSS FeedPosted by Michael Wonder on 28 Jul 2021
Controversy and progress in Alzheimer’s disease — FDA approval of aducanumab
28 July 2021 - The FDA’s accelerated approval of aducanumab represents a landmark moment, though the drug’s road to the clinic ...
Posted by Michael Wonder on 28 Jul 2021
Revisiting FDA approval of aducanumab
28 July 2021 - Given the scientific, regulatory, and clinical implications of the accelerated FDA approval of aducanumab for Alzheimer’s disease, ...
Posted by Michael Wonder on 28 Jul 2021
FDA says its 'working as quickly as possible' to review for full approval of vaccines
27 July 2021 - Some say full approval could sway hesitant Americans to get the vaccine. ...
Posted by Michael Wonder on 27 Jul 2021
How Biogen found a believer: at the FDA, a hard nosed regulator was won over on controversial Alzheimer’s drug
27 July 2021 - When the drug maker Biogen pitched its Alzheimer’s treatment to a panel of independent experts last ...
Posted by Michael Wonder on 26 Jul 2021
Full FDA approval is needed to overcome vaccine hesitancy
26 July 2021 - As the Delta variant spreads, what is the agency waiting for? ...
Posted by Michael Wonder on 23 Jul 2021
Most clinical trials failed to meet U.S. transparency requirements for recently approved drugs
22 July 2021 - In the latest look at clinical trial transparency, a new analysis found that only 26% of ...
Posted by Michael Wonder on 23 Jul 2021
‘When memory fades’: misinformation about Alzheimer’s disease and Aduhelm must be limited
21 July 2021 - Surgeon General Vivek Murthy issued a timely and thought-provoking advisory about the serious threat to public ...
Posted by Michael Wonder on 22 Jul 2021
Roche is discussing Alzheimer’s drug with FDA following regulators controversial approval of Biogen’s Aduhelm, CEO says
22 July 2021 - Roche is discussing its potential Alzheimer’s treatment with the U.S. FDA, CEO Severin Schwan said Thursday, ...
Posted by Michael Wonder on 21 Jul 2021
Recently approved Alzheimer drug raises questions that might never be answered
21 July 2021 - The FDA’s approval June 7 of the drug aducanumab was notable for a number of reasons. ...
Posted by Michael Wonder on 21 Jul 2021
Pfizer provides update on U.S. FDA review of abrocitinib and Xeljanz filings
21 July 2021 - Pfizer announced today that the U.S. FDA has notified the company that it will not meet the ...
Posted by Michael Wonder on 21 Jul 2021
How an unproven Alzheimer’s drug got approved
19 July 2021 - Though some of its own senior officials said there was little evidence of benefit for patients, the ...
Posted by Michael Wonder on 19 Jul 2021
Making sense of the FDA’s ‘indefensible’ decision to approve Aduhelm
19 July 2021 - There are three sides to every story that defies logic: the defenders’ side, the critics’ side and ...
Posted by Michael Wonder on 14 Jul 2021
FDA chief tells reporter ‘move on’ when pressed on Biogen Alzheimer’s drug approval
14 July 2021 - Acting FDA Commissioner Dr. Janet Woodcock pushed back against questions from a journalist about the approval of ...
Posted by Michael Wonder on 14 Jul 2021
FDA chief Janet Woodcock acknowledges agency may have misstepped in process leading up to Alzheimer’s drug approval
14 July 2021 - Acting FDA Commissioner Janet Woodcock acknowledged on Wednesday her agency may have misstepped in its handling ...
Posted by Michael Wonder on 14 Jul 2021
Harvard doctor urges FDA reforms after Biogen Alzheimer nod
13 July 2021 - Curtail biomarker use for clearance, Kesselheim writes in JAMA. ...