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RSS FeedPosted by Michael Wonder on 09 Apr 2024
Syros receives fast track designation from the FDA for tamibarotene for the treatment of newly diagnosed unfit AML with RARA gene over-expression
9 April 2024 - Syros Pharmaceuticals today announced that the US FDA has granted fast track designation to tamibarotene in ...
Posted by Michael Wonder on 09 Apr 2024
Using effect scores to characterise heterogeneity of treatment effects
9 April 2024 - It is common for treatments to yield different outcomes in different patients. If patient characteristics that predict ...
Posted by Michael Wonder on 09 Apr 2024
ViiV Healthcare announces US FDA approval of Dovato (dolutegravir/lamivudine) for adolescents living with HIV
8 April 2024 - Dovato is now the first and only oral, two drug, single-tablet regimen available for people aged 12 ...
Posted by Michael Wonder on 09 Apr 2024
Shorla Oncology announces FDA filing acceptance of new drug application to treat certain forms of leukaemia and other cancers
8 April 2024 - Second FDA acceptance for an NDA filing by Shorla Oncology announced in 2024. ...
Posted by Michael Wonder on 09 Apr 2024
Supernus provides regulatory update for SPN-830
8 April 2024 - Supernus Pharmaceuticals today announced a regulatory update for SPN-830. ...
Posted by Michael Wonder on 08 Apr 2024
Stealth BioTherapeutics announces FDA acceptance of new drug application for elamipretide for the treatment of Barth syndrome
8 April 2024 - If approved, elamipretide would become the first approved therapy for Barth syndrome. ...
Posted by Michael Wonder on 08 Apr 2024
Phanes Therapeutics' PT217 granted fast track designation by the FDA
8 April 2024 - Phanes Therapeutics announced today that the US FDA has granted fast track designation to PT217 for the ...
Posted by Michael Wonder on 08 Apr 2024
ARS Pharmaceuticals submits response to FDA complete response letter for neffy (epinephrine nasal spray)
3 April 2024 - Submission of complete response letter response triggers up to six month review period by the FDA. ...
Posted by Michael Wonder on 08 Apr 2024
Clinical benefit and regulatory outcomes of cancer drugs receiving accelerated approval
7 April 2024 - In this cohort study of cancer drugs granted accelerated approval from 2013 to 2017, 41% (19/46) did ...
Posted by Michael Wonder on 08 Apr 2024
Carvykti is the first and only BCMA targeted treatment approved by the US FDA for patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy
5 April 2024 - Approval is based on results from the Phase 3 CARTITUDE-4 study, in which treatment with Carvykti ...
Posted by Michael Wonder on 07 Apr 2024
FDA grants breakthrough therapy designation to sunvozertinib for the first-line treatment of patients with advanced non-small cell lung cancer harboring EGFR exon 20 insertion mutations
7 April 2024 - Dizal today announced that the US FDA has granted breakthrough therapy designation to its sunvozertinib as ...
Posted by Michael Wonder on 05 Apr 2024
FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2 positive solid tumours
5 April 2024 - Today, the FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for adult patients with ...
Posted by Michael Wonder on 05 Apr 2024
US FDA approves Bristol Myers Squibb and 2seventy bio’s Abecma for triple-class exposed relapsed or refractory multiple myeloma after two prior lines of therapy
5 April 2024 - Abecma tripled progression-free survival compared to standard regimens in the Phase 3 KarMMa-3 trial, with a 51% ...
Posted by Michael Wonder on 04 Apr 2024
Amylyx Pharmaceuticals announces formal intention to remove Relyvrio/Albrioza from the market
4 April 2024 - Based on top-line results from the Phase 3 PHOENIX trial of AMX0035 in ALS, Amylyx has started ...
Posted by Michael Wonder on 04 Apr 2024
FDA accepts supplemental biologics license applications for Bimzelx (bimekizumab-bkzx) for moderate to severe hidradenitis suppurativa and additional 2 mL device presentations
4 April 2024 - Application in moderate to severe hidradenitis suppurativa based on results from two Phase 3 studies where ...