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RSS FeedPosted by Michael Wonder on 07 Dec 2020
FDA could authorise Pfizer’s COVID-19 vaccine this week as U.S. deaths surge
7 December 2020 - An FDA advisory group is scheduled to convene on Thursday to review Pfizer’s vaccine. ...
Posted by Michael Wonder on 07 Dec 2020
Immunicum receives FDA fast track designation for ilixadencel in gastro-intestinal stromal tumours
7 December 2020 - Immunicum announced today that it has received fast track designation from the U.S. FDA for the Company’s ...
Posted by Michael Wonder on 07 Dec 2020
Scynexis announces FDA acceptance and priority review of new drug application for oral ibrexafungerp for the treatment of vaginal yeast infections
7 December 2020 - 6 month Priority Review granted for ibrexafungerp with PDUFA target action date set for 1 June 2021. ...
Posted by Michael Wonder on 07 Dec 2020
Chimerix announces FDA acceptance of new drug application for brincidofovir as a medical countermeasure for smallpox
7 December 2020 - Chimerix today announced that the U.S. FDA has accepted the filing of a new drug application ...
Posted by Michael Wonder on 07 Dec 2020
scPharmaceuticals receives complete response letter from FDA for Furoscix
7 December 2020 - Complete response letter did not identify clinical deficiencies. ...
Posted by Michael Wonder on 07 Dec 2020
Janssen seeks EU approval for twice yearly schizophrenia treatment
7 December 2020 - Janssen has submitted a marketing authorisation extension application to the EMA for paliperidone palmitate six monthly ...
Posted by Michael Wonder on 06 Dec 2020
How COVID-19 vaccines are being approved in Canada
5 December 2020 - Measures have been taken to expedite the approval process. ...
Posted by Michael Wonder on 06 Dec 2020
The elderly vs. essential workers: who should get the coronavirus vaccine first?
5 December 2020 - The C.D.C. will soon decide which group to recommend next, and the debate over the trade-offs is ...
Posted by Michael Wonder on 06 Dec 2020
HHS’s Alex Azar says Pfizer vaccine could receive green light within days
6 December 2020 - The top U.S. health official said the federal government could authorise Pfizer’s COVID-19 vaccine within days ...
Posted 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 ...