Blog
RSS FeedPosted by Michael Wonder on 09 Nov 2020
FDA approves liquid biopsy NGS companion diagnostic test for multiple cancers and biomarkers
9 November 2020 - On 6 November, the FDA approved the FoundationOne Liquid CDx test as a companion diagnostic device to ...
Posted by Michael Wonder on 09 Nov 2020
Impel Neuropharma announces FDA submission of new drug application for INP104 for the acute treatment of migraine
9 November 2020 - The INP104 new drug application is supported by results from the Phase 3 STOP 301 trial. ...
Posted by Michael Wonder on 09 Nov 2020
FDA grants rare paediatric disease designation to AMO Pharma for AMO-02 for treatment of congenital myotonic dystrophy
9 November 2020 - Designation qualifies AMO-02 for fast track review and AMO Pharma to receive a priority review voucher pending ...
Posted by Michael Wonder on 09 Nov 2020
Novavax COVID-19 vaccine granted fast track designation by U.S. FDA
9 November 2020 - Novavax today announced that the U.S. FDA has granted fast track designation for NVX-CoV2373, the Company’s COVID-19 ...
Posted by Michael Wonder on 09 Nov 2020
Liminal BioSciences announces FDA extension of review period for Ryplazim (plasminogen) BLA
9 November 2020 - PDUFA date extended by FDA from 5 March 2021 to 5 June 2021. ...
Posted by Michael Wonder on 09 Nov 2020
FDA permits marketing of new device designed to reduce sleep disturbance related to nightmares in certain adults
6 November 2020 - Today, the U.S. FDA permitted marketing of a new device intended for the temporary reduction of sleep ...
Posted by Michael Wonder on 09 Nov 2020
AFT welcomes US FDA complete response letter
9 November 2020 - AFT Pharmaceuticals today announces it has received a US FDA complete response letter covering its application ...
Posted by Michael Wonder on 09 Nov 2020
Makena indication may fall based on post-approval data
6 November 2020 - The US FDA is seeking to withdraw the approval of the only drug indicated to prevent ...
Posted by Michael Wonder on 07 Nov 2020
Ligand's partner Sedor Pharmaceuticals receives FDA approval for Sesquient for the treatment of status epilepticus in adult and paediatric patients
6 November 2020 - Captisol enabled product is stable at room temperature for timely administration at the point of patient care. ...
Posted by Michael Wonder on 06 Nov 2020
Brilinta approved in the US to reduce the risk of stroke in patients with an acute ischaemic stroke or high-risk transient ischaemic attack
6 November 2020 - New indication expands use of Brilinta beyond cardiovascular disease to patients with mild-to-moderate stroke ...
Posted by Michael Wonder on 04 Nov 2020
LogicBio Therapeutics receives FDA fast track designation for LB-001 for the treatment of methylmalonic acidemia
4 November 2020 - LogicBio Therapeutics announced today the U.S. FDA has granted fast track designation to its clinical candidate, LB-001 ...
Posted by Michael Wonder on 04 Nov 2020
Salvia BioElectronics receives FDA breakthrough device designation for innovative neurostimulation solution
3 November 2020 - Salvia BioElectronics announced today that the U.S, FDA has granted breakthrough device designation for its implantable ...
Posted by Michael Wonder on 03 Nov 2020
Regulatory policy may not stop comparative efficacy trials
4 November 2020 - The way Sarfaraz K. Niazi, looks at it, doing comparative efficacy studies in humans to confirm that ...
Posted by Michael Wonder on 03 Nov 2020
FDA approves updated label for Endari
3 November 2020 - Emmaus Life Sciences announced today revised prescribing information for Endari to better inform healthcare professionals and sickle ...
Posted by Michael Wonder on 03 Nov 2020
Is it time for the FDA to be independent?
3 November 2020 - Public health experts and lay observers alike have expressed concerns that, under political pressure, the FDA ...