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RSS FeedPosted by Michael Wonder on 08 Jun 2024
Moderna files FDA application for the JN.1 targeting COVID-19 vaccine
7 June 2024 - Manufacturing is underway and doses of Moderna's Spikevax 2024-2025 formula will be ready to ship as ...
Posted by Michael Wonder on 08 Jun 2024
Updated COVID-19 vaccines for use in the United States beginning in fall 2024
7 June 2024 - The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on 5 June 2024 to ...
Posted by Michael Wonder on 07 Jun 2024
FDA approves imetelstat for low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anaemia
6 June 2024 - Today, the FDA approved imetelstat (Rytelo, Geron Corporation), an oligonucleotide telomerase inhibitor, for adults with low- ...
Posted by Michael Wonder on 06 Jun 2024
BlueRock Therapeutics receives FDA Regenerative Medicine Advanced Therapy designation for Parkinson’s disease cell therapy candidate bemdaneprocel
31 May 2024 - Regenerative Medicine Advanced Therapy designation follows phase I clinical trial results demonstrating that bemdaneprocel is well tolerated ...
Posted by Michael Wonder on 06 Jun 2024
Neurogene announces NGN-401 gene therapy for Rett syndrome selected by FDA for START pilot program
3 June 2024 - NGN-401 is one of only three CBER programs chosen by FDA. ...
Posted by Michael Wonder on 06 Jun 2024
Denali Therapeutics announces FDA has selected DNL126 for MPS IIIA (Sanfilippo syndrome type A) for START pilot program intended to accelerate development of rare disease therapies
3 June 2024 - START is a pilot program newly launched jointly by the FDA CDER and CBER divisions to further ...
Posted by Michael Wonder on 06 Jun 2024
Moderna's investigational therapeutic for methylmalonic acidaemia (mRNA-3705) selected by US FDA for START pilot program
6 June 2024 - Center for Biologics Evaluation and Research has chosen mRNA-3705 as one of four investigational medicines for ...
Posted by Michael Wonder on 06 Jun 2024
FDA accepts for review treosulfan NDA resubmission
6 June 2024 - Today, Medexus Pharmaceuticals was informed by medac, licensor of Medexus's commercialisation rights to treosulfan, that the ...
Posted by Michael Wonder on 05 Jun 2024
Catalyst Pharmaceuticals receives US FDA approval for increased maximum daily dose for Firdapse
30 May 2024 - Catalyst Pharmaceuticals today announced that the US FDA has approved its supplemental new drug application increasing the ...
Posted by Michael Wonder on 05 Jun 2024
Why should the FDA focus on pragmatic clinical research?
3 June 2024 - Traditional randomised clinical trials have long been a key tool underpinning drug and device development. ...
Posted by Michael Wonder on 05 Jun 2024
Adicet Bio receives FDA fast track designation for ADI-001 in lupus nephritis
5 June 2024 - Adicet Bio today announced the US FDA has granted fast track designation to ADI-001 for the potential ...
Posted by Michael Wonder on 05 Jun 2024
TScan Therapeutics receives FDA’s regenerative medicine advanced therapy designation for its two lead TCR-T therapy candidates for the treatment of heme malignancies
29 May 2024 - RMAT designation granted for both TSC-100 and TSC-101 for the treatment of patients with AML, ALL, and ...
Posted by Michael Wonder on 05 Jun 2024
uniQure receives FDA regenerative medicine advanced therapy designation for investigational gene therapy AMT-130 in Huntington’s disease
3 June 2024 - Designation based on 24 month interim Phase 1/2 clinical data for AMT-130 announced in December 2023. ...
Posted by Michael Wonder on 05 Jun 2024
Johnson & Johnson submits supplemental new drug application to US FDA seeking expanded paediatric indication for HIV-1 therapy Prezcobix
4 June 2024 - Johnson & Johnson today announced the submission of a supplemental new drug application to the US FDA ...
Posted by Michael Wonder on 05 Jun 2024
Quince Therapeutics receives US FDA fast track designation for EryDex system
3 June 2024 - Quince Therapeutics today announced that the US FDA has granted fast track designation for its EryDex System ...