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RSS FeedPosted by Michael Wonder on 24 Sep 2020
FDA authorises first point of care antibody test for COVID-19
23 September 2020 - Today, the U.S. FDA issued an emergency use authorisation for the first serology (antibody) point of care ...
Posted by Michael Wonder on 24 Sep 2020
Leap Therapeutics announces FDA fast track designation granted to DKN-01 for the treatment of gastric and gastro-esophageal junction cancer
24 September 2020 - Leap Therapeutics today announced that the U.S. FDA has granted fast track designation to DKN-01 for the ...
Posted by Michael Wonder on 24 Sep 2020
Trump claims White House can overrule FDA's attempt to toughen guidelines for coronavirus vaccine
24 September 2020 - President Donald Trump claimed Wednesday that the White House could override the US FDA if the ...
Posted by Michael Wonder on 24 Sep 2020
Telix Pharmaceuticals submits new drug application to US FDA for prostate cancer imaging product
24 September 2020 - Telix Pharmaceuticals today announces it has submitted a new drug application to the United States FDA for ...
Posted by Michael Wonder on 24 Sep 2020
Guideline on registry-based studies - launch of public consultation
24 September 2020 - EMA has published its draft Guideline on registry-based studies for a three-month public consultation today. ...
Posted by Michael Wonder on 24 Sep 2020
GW Pharmaceuticals receives Australian Therapeutic Goods Administration approval for Epidyolex (cannabidiol) for the treatment of seizures in patients with two rare, severe forms of childhood-onset epilepsy
23 September 2020 - This represents the third successful regulatory approval globally for GW’s plant-derived cannabis-based medicine. ...
Posted by Michael Wonder on 23 Sep 2020
FDA poised to announce tougher standards for a COVID-19 vaccine that make it unlikely one will be cleared by Election Day
23 September 2020 - The guidance is part of an effort to boost transparency and public trust as polls show many ...
Posted by Michael Wonder on 23 Sep 2020
How incidents with medicines are managed in the EU – a ten year analysis
23 September 2020 - The EU medicines network is supported by a robust regulatory framework with defined processes and clear ...
Posted by Michael Wonder on 23 Sep 2020
FDA accepts supplemental new drug application for Pfizer’s Xalkori (crizotinib) for the treatment of paediatric ALK positive anaplastic large cell lymphoma
23 September 2020 - If approved, Xalkori would be the first biomarker driven therapy for paediatric ALK positive anaplastic large cell ...
Posted by Michael Wonder on 23 Sep 2020
FDA grants RMAT designation to MultiStem cell therapy for the treatment of acute respiratory distress syndrome
23 September 2020 - ARDS program well positioned for an expedited path to commercialisation with RMAT and fast track designation. ...
Posted by Michael Wonder on 23 Sep 2020
Eisai receives positive opinion from EMA's CHMP on use of anti-epileptic agent Fycompa in paediatric patients
23 September 2020 - Eisai announced that it has received a positive opinion from the EMA’s CHMP on the license extension ...
Posted by Michael Wonder on 23 Sep 2020
Australia now eligible to purchase COVID-19 vaccine doses through COVAX
23 September 2020 - The Australian Government has joined the COVAX facility, enabling the purchase of COVID-19 vaccine doses as they ...
Posted by Michael Wonder on 23 Sep 2020
UCB achieves important regulatory milestone for bimekizumab
22 September 2020 - The U.S. FDA and EMA have accepted marketing application submissions for bimekizumab for the treatment of adults ...
Posted by Michael Wonder on 23 Sep 2020
Instrumentation Laboratory receives US FDA marketing authorisation for the first apixaban diagnostic test
22 September 2020 - The first direct oral anticoagulant test authorised for clinical use on automated hemostasis systems. ...
Posted by Michael Wonder on 23 Sep 2020
Liminal BioSciences provides update on progress on BLA for Ryplazim (plasminogen)
21 September 2020 - FDA assigns PDUFA target action date of 5 March 2021. ...