Blog
RSS FeedPosted by Michael Wonder on 23 Aug 2023
Futility in clinical trials
31 July 2023 - The primary objectives of a confirmatory clinical trial, namely a clinical trial conducted with the intention of ...
Posted by Michael Wonder on 21 Aug 2023
Geron announces FDA acceptance of new drug application for imetelstat for the treatment of lower risk MDS
21 August 2023 - Geron Corporation today announced that the US FDA has accepted the filing of Geron’s new drug application ...
Posted by Michael Wonder on 19 Aug 2023
Neurocrine Biosciences announces FDA approval of Ingrezza (valbenazine) capsules for the treatment of chorea associated with Huntington's disease
18 August 2023 - Neurocrine Biosciences today announced the US FDA has approved Ingrezza (valbenazine) capsules for the treatment of ...
Posted by Michael Wonder on 19 Aug 2023
Eylea HD (aflibercept) 8 mg injection approved by FDA for treatment of wet age-related macular degeneration, diabetic macular oedema and diabetic retinopathy
18 August 2023 - Approval based on the pivotal PULSAR and PHOTON trials in which Eylea HD demonstrated clinically equivalent vision ...
Posted by Michael Wonder on 19 Aug 2023
Veopoz (pozelimab-bbfg) receives FDA approval as the first treatment for children and adults with CHAPLE disease
18 August 2023 - Approval represents tenth FDA approved medicine invented by Regeneron. ...
Posted by Michael Wonder on 18 Aug 2023
FDA grants priority review for full approval of Tarpeyo for the treatment of IgA nephropathy
18 August 2023 - Calliditas Therapeutics today announced that the US FDA has accepted the submission for the supplemental new ...
Posted by Michael Wonder on 16 Aug 2023
The collateral damage of ADHD drug shortages
15 August 2023 - As a new school year begins, parents and doctors find medication shortages are leading to declines in ...
Posted by Michael Wonder on 16 Aug 2023
US FDA approves Ipsen’s Sohonos (palovarotene) capsules, the first and only treatment for people with fibrodysplasia ossificans progressiva
16 August 2023 - Sohonos may be prescribed immediately in the US for eligible patients, aged 8 years and older ...
Posted by Michael Wonder on 16 Aug 2023
Servier announces FDA filing acceptance and priority review for Tibsovo (ivosidenib tablets) in the treatment of IDH1 mutated relapsed or refractory myelodysplastic syndromes
15 August 2023 - Submission supported by comprehensive clinical data package, including updated results that demonstrate durable remissions and an ...
Posted by Michael Wonder on 15 Aug 2023
US FDA approves FoundationOne CDx as a companion diagnostic for Janssen’s Akeega (niraparib and abiraterone acetate dual action tablet) for patients with BRCA positive metastatic castration-resistant prostate cancer
14 August 2023 - Foundation Medicine’s tissue-based comprehensive genomic profiling test is now FDA approved to identify patients with metastatic castration-resistant ...
Posted by Michael Wonder on 15 Aug 2023
Delcath Systems announces FDA approval of Hepzato Kit for the treatment of adult patients with unresectable hepatic dominant metastatic uveal melanoma
14 August 2023 - Hepzato Kit is the only FDA approved liver directed therapy to treat metastatic uveal melanoma. ...
Posted by Michael Wonder on 15 Aug 2023
Lactiga receives FDA rare paediatric disease designation for groundbreaking mucosal immunoglobulin therapy for common variable immunodeficiency disease
14 August 2023 - LCTG-001 on course to be the first FDA approved biologic from human milk. ...
Posted by Michael Wonder on 14 Aug 2023
FDA grants accelerated approval to elranatamab-bcmm for multiple myeloma
14 August 2023 - Today, the FDA granted accelerated approval to elranatamab-bcmm (Elrexfio, Pfizer), a bispecific B-cell maturation antigen directed ...
Posted by Michael Wonder on 14 Aug 2023
US FDA approves first therapeutic indication for Revance’s Daxxify (daxibotulinumtoxinA-lanm) for injection for the treatment of cervical dystonia
14 August 2023 - Approval expands the Daxxify label to include efficacy data over the 52 week ASPEN repeat dose clinical ...
Posted by Michael Wonder on 14 Aug 2023
In the case of a devastating disease, the FDA weighs an experimental drug’s muddled data and a desperate need
14 August 2023 - Emma Albee knows the experimental drug she takes is not a cure. It won’t allow her ...