Blog
RSS FeedPosted by Michael Wonder on 27 Dec 2022
Harm Reduction Therapeutics' new drug application for RiVive over the counter naloxone nasal spray accepted and granted priority review by FDA
26 December 2022 - Low cost, over the counter naloxone nasal spray advances to FDA review. Approval would increase access ...
Posted by Michael Wonder on 18 Dec 2022
US FDA designates Alexis Bio's realSKIN as regenerative medicine advanced therapy
15 December 2022 - Alexis Bio today announced that realSKIN is the first live cell xenotransplant product to be designated ...
Posted by Michael Wonder on 07 Dec 2022
US FDA accepts for priority review the biologics license application for Pfizer’s respiratory syncytial virus vaccine candidate for the prevention of RSV disease in older adults
7 December 2022 - If approved, RSVpreF would help address the substantial burden of RSV disease in individuals 60 years ...
Posted by Michael Wonder on 01 Dec 2022
Innoviva announces FDA acceptance and priority review of new drug application for sulbactam-durlobactam
30 November 2022 - Sulbactam-durlobactam is a targeted antibiotic that was specifically designed to treat serious infections caused by Acinetobacter baumannii, ...
Posted by Michael Wonder on 30 Nov 2022
Evkeeza (evinacumab-dgnb) sBLA for children with ultra rare inherited form of high cholesterol accepted for FDA priority review
30 November 2022 - If approved, Evkeeza would be the first and only treatment of its kind to help children ...
Posted by Michael Wonder on 30 Nov 2022
argenx enters into agreement to acquire priority review voucher
30 November 2022 - argenx today announced an agreement to acquire a US FDA priority review voucher for $102 million. ...
Posted by Michael Wonder on 29 Nov 2022
Caribou Biosciences announces the FDA granted regenerative medicine advanced therapy and fast track designations to CB-010, an allogeneic anti-CD19 CAR-T cell therapy
29 November 2022 - CB-010 is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout. ...
Posted by Michael Wonder on 28 Nov 2022
Sarepta Therapeutics announces that US FDA has accepted for filing and granted priority review for the biologics license application for SRP-9001, Sarepta’s gene therapy for the treatment of ambulant individuals with Duchenne muscular dystrophy
28 November 2022 - Regulatory action date of 29 May 2023. ...
Posted by Michael Wonder on 23 Nov 2022
Takeda’s biologics license application for Dengue vaccine candidate (TAK-003) granted priority review by US FDA
23 November 2022 - TAK-003 is being evaluated for the prevention of Dengue disease caused by any Dengue virus serotype ...
Posted by Michael Wonder on 22 Nov 2022
argenx announces US FDA acceptance of biologics license application for subcutaneous efgartigimod in generalised myasthenia gravis with priority review
22 November 2022 - PDUFA target action date is 20 March 2023. ...
Posted by Michael Wonder on 21 Nov 2022
US FDA accepts for priority review the biologics license application for epcoritamab (DuoBody-CD3xCD20) for the treatment of relapsed/refractory large B-cell lymphoma
21 November 2022 - The application is supported by data from EPCORE NHL-1 Phase 1/2 trial evaluating the safety and preliminary ...
Posted by Michael Wonder on 11 Nov 2022
Akari Therapeutics granted FDA rare paediatric disease designation of nomacopan for the treatment of paediatric HSCT-TMA
10 November 2022 - Akari Therapeutics today announced the US FDA has granted the rare paediatric disease designation to nomacopan for ...
Posted by Michael Wonder on 09 Nov 2022
Study: high concordance in breakthrough therapy, PRIME decisions
8 November 2022 - The US FDA and the EMA agreed on nearly two-thirds of decisions to grant or deny ...
Posted by Michael Wonder on 07 Nov 2022
Sensorion announces US FDA grants rare paediatric disease designation to OTOF-GT for the treatment of otoferlin gene-mediated hearing loss
7 November 2022 - OTOF-GT targets the restoration of hearing in people living with otoferlin deficiency. ...
Posted by Michael Wonder on 02 Nov 2022
GSK’s respiratory syncytial virus older adult vaccine candidate granted priority review by US FDA
2 November 2022 - US FDA has set a Prescription Drug User Fee Act action date of 3 May 2023. ...