Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 29 Aug 2024
FDA grants priority review to SpringWorks Therapeutics’ new drug application for mirdametinib for the treatment of adults and children with neurofibromatosis type 1-associated plexiform neurofibromas
28 August 2024 - PDUFA target action date of 28 February 2025. ...
Posted by Michael Wonder on 29 Aug 2024
Life Molecular Imaging receives FDA fast track designation for [18F]PI-2620 in Tau PET imaging across three neurodegenerative conditions
28 August 2024 - Life Molecular Imaging is pleased to announce that the US FDA granted fast track designation to [18F]PI-2620 ...
Posted by Michael Wonder on 28 Aug 2024
Telix submits NDA for TLX101-CDx (Pixclara) brain cancer imaging agent
28 August 2024 - Telix today announces it has submitted a new drug application to the US FDA for TLX101-CDx, (Pixclara, ...
Posted by Michael Wonder on 28 Aug 2024
Cigna to remove AbbVie's Humira from some drug reimbursement lists next year
26 August 2024 - Cigna said on Monday it will remove AbbVie’s rheumatoid arthritis drug Humira from some of its ...
Posted by Michael Wonder on 28 Aug 2024
Lilly releases Zepbound (tirzepatide) single-dose vials, expanding supply and access for adults living with obesity
27 August 2024 - Eli Lilly today announced Zepbound (tirzepatide) 2.5 mg and 5 mg single-dose vials are available for self-pay ...
Posted by Michael Wonder on 27 Aug 2024
Soleno Therapeutics announces US FDA acceptance for filing and priority review of NDA for DCCR (diazoxide choline) extended release tablets in Prader-Willi syndrome
27 August 2024 - Soleno Therapeutics today announced that the US FDA has accepted for filing its new drug application ...
Posted by Michael Wonder on 27 Aug 2024
FDA grants fast track designation for bexmarilimab
26 August 2024 - Faron Pharmaceuticals today announces that their lead candidate bexmarilimab has been granted fast track designation for the ...
Posted by Michael Wonder on 27 Aug 2024
Rhythm Pharmaceuticals announces FDA acceptance for priority review of supplemental new drug application for Imcivree (setmelanotide) in patients as young as 2 years old
26 August 2024 - FDA sets PDUFA goal date of 26 December 2024. ...
Posted by Michael Wonder on 26 Aug 2024
BeiGene’s BGB-16673 receives US FDA fast track designation for CLL/SLL
26 August 2024 - Designation supported by promising safety and efficacy data from Phase 1/2 study in heavily pretreated patients with ...
Posted by Michael Wonder on 26 Aug 2024
FDA clears first device to enable automated insulin dosing for individuals with type 2 diabetes
26 August 2024 - Agency supports broader access to innovative technology in diabetes management. ...