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RSS FeedPosted by Michael Wonder on 05 Sep 2024
Perspective Therapeutics granted fast track designation for VMT01 for the diagnosis and treatment of MC1R positive melanoma
5 September 2024 - Perspective Therapeutics today announced that the US FDA granted fast track designation for the development of ...
Posted by Michael Wonder on 05 Sep 2024
US FDA approves FoundationOne CDx and FoundationOne Liquid CDx as companion diagnostics for Lynparza (olaparib) in combination with abiraterone for patients with BRCA mutated metastatic castration-resistant prostate cancer
3 September 2024 - Foundation Medicine’s tissue and liquid biopsy tests can now be used to identify more patients who could ...
Posted by Michael Wonder on 05 Sep 2024
Axsome Therapeutics announces FDA acceptance of NDA resubmission for AXS-07 for the acute treatment of migraine
4 September 2024 - Axsome Therapeutics today announced that the US FDA has acknowledged the resubmission of the Company’s new drug ...
Posted by Michael Wonder on 05 Sep 2024
Breakthrough therapies approved based on surrogate endpoints often lack post-marketing requirements
4 September 2024 - The use of surrogate markers to support drug approvals without requiring postmarketing studies can “hinder accurate ...
Posted by Michael Wonder on 05 Sep 2024
Synthekine granted US FDA fast track designation for CD19 CAR-T and orthogonal IL-2 investigational therapy, SYNCAR-001 + STK-009, for the treatment of lupus without lymphodepletion
4 September 2024 - Synthekine today announced that the US FDA has granted fast track designation to SYNCAR-001 + STK-009, ...
Posted by Michael Wonder on 05 Sep 2024
Innovent receives fast track designation from the US FDA for IBI363 (PD-1/IL-2α bispecific antibody fusion protein) as monotherapy for advanced melanoma
4 September 2024 - Innovent Biologics announced that the US FDA has granted fast track designation to its PD-1/IL-2α bispecific antibody ...
Posted by Michael Wonder on 04 Sep 2024
Unicycive Therapeutics announces submission of the new drug application to the US FDA for oxylanthanum carbonate for the treatment of hyperphosphataemia in patients with chronic kidney disease on dialysis
3 September 2024 - Unicycive Therapeutics today announced that the Company has submitted a new drug application to the US FDA ...
Posted by Michael Wonder on 03 Sep 2024
Obsidian Therapeutics receives FDA regenerative medicine advanced therapy designation for OBX-115 for the treatment of advanced melanoma
3 September 2024 - Obsidian Therapeutics today announced that the US FDA has granted regenerative medicine advanced therapy designation to ...
Posted by Michael Wonder on 03 Sep 2024
Caribou Biosciences announces the FDA has granted fast track designations to CB-010 in refractory SLE and to CB-012 in relapsed or refractory AML
3 September 2024 - Additional FDA designation for CB-010 following earlier RMAT and fast track designations in B-NHL. ...
Posted by Michael Wonder on 02 Sep 2024
CAMP4 Therapeutics secures rare paediatric disease designation for CMP-CPS-001 for the treatment of urea cycle disorders
27 August 2024 - CAMP4 Therapeutics today announced the US FDA has granted rare paediatric disease designation to the Company’s lead ...
Posted by Michael Wonder on 01 Sep 2024
Ipsen announces sale of priority review voucher for $158 million
27 August 2024 - Ipsen has entered into an agreement to sell its rare paediatric disease priority review voucher to ...
Posted by Michael Wonder on 01 Sep 2024
FDA authorises updated Novavax COVID-19 vaccine to better protect against currently circulating variants
30 August 2024 - Today, the US FDA granted emergency use authorisation for an updated version of the Novavax COVID-19 vaccine ...
Posted by Michael Wonder on 30 Aug 2024
Emergent BioSolutions’ Acam2000 (smallpox and mpox (Vaccinia) vaccine, live) receives US FDA approval for mpox indication
29 August 2024 - Emergent BioSolutions today announced that the US FDA has approved the supplemental biologics license application for the ...
Posted by Michael Wonder on 29 Aug 2024
Johnson & Johnson seeks first approval of nipocalimab to treat broadest population living with antibody positive generalised myasthenia gravis
29 August 2024 - Filing based on the Phase 3 Vivacity-MG3 program, the first-and-only study results in the class demonstrating sustained ...
Posted by Michael Wonder on 29 Aug 2024
FDA approves Illumina cancer biomarker test with two companion diagnostics to rapidly match patients to targeted therapies
27 August 2024 - TruSight Oncology Comprehensive is the first US FDA approved, distributable comprehensive genomic profiling Iin vitro diagnostic kit ...