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RSS FeedPosted by Michael Wonder on 05 Dec 2020
FDA approves weight management drug for patients aged 12 and older
4 December 2020 - The U.S. FDA has approved Saxenda (liraglutide) for chronic weight management among patients aged 12 and older ...
Posted by Michael Wonder on 05 Dec 2020
Pfizer slashes its original COVID-19 vaccine rollout target after supply-chain obstacles
4 December 2020 - Pfizer expects to ship half of the COVID-19 vaccines it originally planned for this year because ...
Posted by Michael Wonder on 04 Dec 2020
Novo Nordisk files for US FDA regulatory approval of once-weekly semaglutide 2.4 mg for weight management
4 December 2020 - Novo Nordisk today announced the submission of a new drug application to the US FDA for subcutaneous ...
Posted by Michael Wonder on 04 Dec 2020
BioCryst announces FDA approval of Orladeyo (berotralstat), first oral, once-daily therapy to prevent attacks in hereditary angioedema patients
3 December 2020 - Significant and sustained reduction in HAE attacks. ...
Posted by Michael Wonder on 04 Dec 2020
ICER opens nominations for new members of its voting panels
2 December 2020 - Independent panel members debate the evidence on the effectiveness and value of new drugs and other ...
Posted by Michael Wonder on 04 Dec 2020
Access Consortium statement on COVID-19 vaccines evidence
4 December 2020 - The medicine regulators from Australia, Canada, Singapore, Switzerland and the United Kingdom (Access Consortium) have discussed the ...
Posted by Michael Wonder on 04 Dec 2020
enGene receives fast track designation for EG-70 for the treatment of non-muscle invasive bladder cancer
3 December 2020 - enGene announced today that the U.S. FDA has granted fast track designation to enGene for EG-70, the ...
Posted by Michael Wonder on 03 Dec 2020
Catalyst Biosciences receives FDA fast track designation for subcutaneous MarzAA for the treatment of episodic bleeding in haemophilia A or B with inhibitors
2 December 2020 - Catalyst Biosciences today announced the U.S. FDA has granted fast track designation for marzeptacog alfa (activated) – ...
Posted by Michael Wonder on 03 Dec 2020
Genmab announces that Janssen has submitted a biologics license application to U.S. FDA for amivantamab in non-small cell lung cancer
3 December 2020 - First regulatory submission for a DuoBody product candidate. ...
Posted by Michael Wonder on 03 Dec 2020
Lilly announces 650,000 additional doses of neutralising antibody bamlanivimab (LY-CoV555) purchased by U.S. government to treat COVID-19
2 December 2020 - The U.S. government has purchased 650,000 additional doses of Eli Lilly and Company's neutralising antibody bamlanivimab (LY-CoV555) ...
Posted by Michael Wonder on 03 Dec 2020
The real worth of cancer drugs
1 December 2020 - In November, 2020, we witnessed one of the most awaited elections in recent times—the USA elected Joe ...
Posted by Michael Wonder on 03 Dec 2020
Protagonist's hepcidin mimetic candidate PTG-300 receives fast track designation from the U.S. FDA for development in the treatment of polycythemia vera
2 December 2020 - Protagonist Therapeutics today announced that the U.S. FDA has granted fast track designation to PTG-300 in the ...
Posted by Michael Wonder on 03 Dec 2020
Aeglea BioTherapeutics receives FDA rare paediatric disease designation for ACN00177 for the treatment of homocystinuria
1 December 2020 - Company eligible to receive priority review voucher upon FDA approval of ACN00177. ...
Posted by Michael Wonder on 03 Dec 2020
Moleculin announces FDA approves 3 rare paediatric disease designations for WP1066
1 December 2020 - Moleculin Biotech today announced that the US FDA has approved its request for a rare paediatric ...
Posted by Michael Wonder on 03 Dec 2020
FDA grant fast track designation for remestemcel-L in the treatment of acute respiratory distress syndrome due to COVID-19
2 December 2020 - Mesoblast today announced that the United States FDA has granted fast track designation for remestemcel-L in the ...