Blog
RSS FeedPosted by Michael Wonder on 30 Sep 2022
FDA grants accelerated approval to futibatinib for cholangiocarcinoma
30 September 2022 - Today, the Food and Drug Administration granted accelerated approval to futibatinib (Lytgobi, Taiho) for adult patients ...
Posted by Michael Wonder on 21 Sep 2022
The on- and off-ramps of oncology accelerated approval
21 September 2022 - To address ongoing concerns about the implementation of the FDA’s accelerated approval pathway in oncology, a ...
Posted by Michael Wonder on 18 Sep 2022
bluebird bio receives FDA accelerated approval for Skysona gene therapy for early, active cerebral adrenoleukodystrophy
16 September 2022 - Skysona is the first FDA approved therapy shown to slow the progression of neurologic dysfunction in boys ...
Posted by Michael Wonder on 17 Aug 2022
Accelerated approval of cancer drugs: no economic reward for drug makers that conduct confirmatory trials
17 August 2022 - The FDA uses expedited approval of drugs to speed the development and assessment of drugs that address ...
Posted by Michael Wonder on 07 Jul 2022
Accelerated approval - taking the FDA’s concerns seriously
6 July 2022 - User-fee re-authorisation creates new opportunities for the FDA to address issues with its accelerated-approval program, including the ...
Posted by Michael Wonder on 23 Jun 2022
Expediency versus efficacy: re-examining the FDA’s accelerated drug approval process
23 June 2022 - It was precisely 30 years ago, in 1992, that the FDA established the accelerated approval program ...
Posted by Michael Wonder on 29 May 2022
Accelerated approval: unfulfilled promises for FDA’s expedited review program
27 May 2022 - As practicing physicians, approval by the U.S. FDA reassures us that the treatments we prescribe our patients ...
Posted by Michael Wonder on 27 May 2022
Key Senate committee proposes a council to ensure FDA better coordinates on accelerated approvals
27 May 2022 - The Senate is taking pains to avoid another Aduhelm controversy. ...
Posted by Michael Wonder on 06 May 2022
Congress moves toward reforming FDA accelerated approvals, but with pharma friendly concessions
4 May 2022 - House lawmakers are moving a little closer toward cracking down on drugmakers that game the FDA’s ...
Posted by Michael Wonder on 18 Apr 2022
FDA’s breakthrough device program, meant to benefit patients, is delivering the biggest gains for companies
18 April 2022 - Five years ago, the FDA launched a new program with the best of intentions: to speed ...
Posted by Michael Wonder on 11 Apr 2022
Alzheimer's drug makers seek accelerated FDA review despite U.S. coverage decision
8 April 2022 - Eisai and Eli Lilly on Friday said they still plan to seek accelerated U.S. approval for ...
Posted by Michael Wonder on 10 Apr 2022
‘Precedents are important’: Aduhelm coverage restrictions could shape the future of accelerated approval
9 April 2022 - Whither accelerated approval? ...
Posted by Michael Wonder on 17 Mar 2022
Panel scrutinises quick FDA drug approvals
17 March 2022 - A House committee will spotlight an FDA process that’s been criticised as putting some of the ...
Posted by Michael Wonder on 10 Mar 2022
Legislation would set expiration for FDA’s accelerated approvals
9 March 2022 - New legislation, introduced by a top Democrat in the House of Representatives, would codify the U.S. ...
Posted by Michael Wonder on 07 Mar 2022
Key Democrat moves to crack down on FDA accelerated approvals
7 March 2022 - A powerful Democratic lawmaker has introduced a bill that would dramatically rein in the Food and ...