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RSS FeedPosted by Michael Wonder on 25 Jan 2023
The 4 biggest questions about the FDA’s forthcoming changes to accelerated approvals
25 January 2023 - Congress just boosted the FDA’s authority over the post-market clinical trials that are a condition of ...
Posted by Michael Wonder on 19 Jan 2023
Seagen announces FDA accelerated approval of Tukysa (tucatinib) in combination with trastuzumab for people with previously treated RAS wild type, HER2 positive metastatic colorectal cancer
19 January 2023 - First FDA approved treatment in HER2 positive metastatic colorectal cancer. ...
Posted by Michael Wonder on 06 Jan 2023
FDA grants accelerated approval for Alzheimer’s disease treatment
6 January 2023 - Today, the US FDA approved Leqembi (lecanemab-irmb) via the accelerated approval pathway for the treatment of Alzheimer’s ...
Posted by Michael Wonder on 23 Dec 2022
FDA grants accelerated approval to mosunetuzumab-axgb for relapsed or refractory follicular lymphoma
22 December 2022 - Today, the FDA granted accelerated approval to mosunetuzumab-axgb (Lunsumio, Genentech), a bispecific CD20 directed CD3 T-cell ...
Posted by Michael Wonder on 13 Dec 2022
FDA grants accelerated approval to adagrasib for KRAS G12C mutated NSCLC
12 December 2022 - Today, the FDA granted accelerated approval to adagrasib (Krazati, Mirati Therapeutics), a RAS GTPase family inhibitor, ...
Posted by Michael Wonder on 11 Dec 2022
The FDA struggle to withdraw Makena; problems with the accelerated approval process
8 December 2022 - Hydroxyprogesterone caproate (Makena) is an injectable drug for the prevention of preterm birth, ie, birth prior to ...
Posted by Michael Wonder on 08 Dec 2022
Speedier drug approvals hit slowdown as FDA faces scrutiny
7 December 2022 - Expedited drug approvals slowed this year as the FDA’s controversial accelerated pathway came under new scrutiny ...
Posted by Michael Wonder on 22 Nov 2022
GSK provides an update on Blenrep (belantamab mafodotin-blmf) US marketing authorisation
22 November 2022 - GSK today announced it has initiated the process for withdrawal of the US marketing authorisation for Blenrep ...
Posted by Michael Wonder on 21 Nov 2022
FDA cancer chief wants quicker ways to pull failed drugs
17 November 2022 - Makena highlights need to make system more nimble. ...
Posted by Michael Wonder on 15 Nov 2022
FDA grants accelerated approval to mirvetuximab soravtansine-gynx for folate receptor alfa positive, platinum resistant epithelial ovarian, fallopian tube, or peritoneal cancer
14 November 2022 - Today the FDA granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere, ImmunoGen) for adult patients with folate ...
Posted by Michael Wonder on 25 Oct 2022
FDA panel vote highlights accelerated approval concerns
25 October 2022 - Last week’s overwhelming vote in favour of pulling preterm-birth drug Makena from the market — and ...
Posted by Michael Wonder on 20 Oct 2022
What the Makena vote means about accelerated approval, trust, and the FDA
19 October 2022 - On Wednesday, the FDA advisory committee that oversees obstetrics, reproductive, and urologic drugs voted 14-1 that ...
Posted 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 ...