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RSS FeedPosted 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
Calquence approved in the EU for the treatment of chronic lymphocytic leukaemia
9 November 2020 - Calquence demonstrated superior progression-free survival and favourable tolerability in both previously untreated and relapsed or refractory ...
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 08 Nov 2020
Made in Melbourne: lab to start producing promising coronavirus vaccine
8 November 2020 - Global biotech company CSL will begin manufacturing millions of vials of one of the most promising ...
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 07 Nov 2020
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of chemotherapy for first-line treatment of metastatic non-small cell lung cancer
6 November 2020 - Approval based on Phase 3 CheckMate-9LA trial results showing superior overall survival in patients with metastatic non-small ...
Posted by Michael Wonder on 06 Nov 2020
International regulators and WHO join forces to address COVID-19 challenges
6 November 2020 - The International Coalition of Medicines Regulatory Authorities and the World Health Organization have committed to working together ...
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 06 Nov 2020
New drug for gastro-intestinal stromal tumours to be launched in Australia, New Zealand and South East Asia following distribution agreement
5 November 2020 - Qinlock is already approved by the TGA and US FDA. ...
Posted by Michael Wonder on 06 Nov 2020
Clinical Trial Exemption (CTX) scheme renamed as Clinical Trial Approval (CTA) scheme
6 November 2020 - The TGA has changed the name of the Clinical Trial Exemption (CTX) scheme to the Clinical ...
Posted by Michael Wonder on 06 Nov 2020
Genmab announces that Janssen has submitted a Type II variation application to the European Medicines Agency for use of subcutaneous Darzalex (daratumumab) in patients with light-chain amyloidosis
5 November 2020 - Submission is based on data from the Phase 3 ANDROMEDA (AMY3001) trial. ...
Posted by Michael Wonder on 05 Nov 2020
EMA will assess potential COVID-19 vaccine on ‘case by case’ basis
5 November 2020 - Agency will not specify a minimum level of efficacy. ...