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RSS FeedPosted by Michael Wonder on 14 Jun 2021
Ascendis Pharma announces extension of U.S. FDA review period for TransCon hGH (onapegsomatropin) for paediatric growth hormone deficiency
11 June 2021 - Prescription Drug User Fee Act goal date extended by three months for further review of submission to ...
Posted by Michael Wonder on 13 Jun 2021
Unaffordable treatment for severe malaria highlights U.S. drug market pitfalls
11 June 2021 - When Eli Lilly announced in 2017 that it would stop producing quinidine, it was the only ...
Posted by Michael Wonder on 11 Jun 2021
Incyte announces U.S. FDA has extended the new drug application review period for ruxolitinib cream for the treatment of atopic dermatitis
11 June 2021 - Incyte announced today that the U.S. FDA has extended the review period for the new drug ...
Posted by Michael Wonder on 11 Jun 2021
Third member of prestigious FDA panel resigns over approval of Biogen's Alzheimer's drug
10 June 2021 - A third member of a key FDA advisory panel has resigned over the agency's controversial decision to ...
Posted by Michael Wonder on 11 Jun 2021
Sanofi provides update on Aubagio (teriflunomide) submission for children and adolescents with relapsing-remitting multiple sclerosis in the U.S
11 June 2021 - The U.S. FDA has issued a complete response letter regarding the supplemental new drug application for ...
Posted by Michael Wonder on 11 Jun 2021
Moderna files for emergency use authorisation for its COVID-19 vaccine in adolescents in the United States
10 June 2021 - Submission based on Phase 2/3 trial of mRNA-1273 in adolescents ages 12 to less than 18 ...
Posted by Michael Wonder on 11 Jun 2021
International regulators and WHO address need to boost COVID-19 vaccine confidence
11 June 2021 - The International Coalition of Medicines Regulatory Authorities and the World Health Organization have jointly developed a statement ...
Posted by Michael Wonder on 11 Jun 2021
Controversial Alzheimer’s drug approved in U.S. Where does Canada stand?
10 June 2021 - The Alzheimer Society of Canada welcomed the new treatment urging Canadian health authorities to complete its required ...
Posted by Michael Wonder on 11 Jun 2021
U.S. FDA approves new formulation of Epclusa, expanding paediatric indication to treat children ages 3 and older with chronic hepatitis C
10 June 2021 - Gilead Sciences announced today that the U.S. FDA has approved an expansion of the pediatric indication of ...
Posted by Michael Wonder on 10 Jun 2021
America’s approval of an Alzheimer’s drug is premature
12 June 2021 - It may offer false hope and divert resources from more promising therapies. ...
Posted by Michael Wonder on 10 Jun 2021
Health Canada grants interim order authorisation for casirivimab and imdevimab for the treatment of mild to moderate COVID-19
10 June 2021 - Interim data shows treatment with casirivimab and imdevimab resulted in a statistically significant reduction in viral ...
Posted by Michael Wonder on 10 Jun 2021
FDA accepts filing of abbreviated new drug application and grants priority review for nalmefene hydrochloride injection for the treatment of known or suspected opioid overdose
10 June 2021 - Purdue Pharma announced that FDA has accepted and granted priority review to the company’s abbreviated new ...
Posted by Michael Wonder on 10 Jun 2021
Core patient reported outcomes in cancer clinical trials
9 June 2021 - This guidance provides recommendations to sponsors for collection of a core set of patient reported clinical outcomes ...
Posted by Michael Wonder on 10 Jun 2021
COVID-19 vaccine weekly safety report (10 June 2021)
10 June 2021 - Seven additional cases of blood clots with low blood platelets have been assessed as thrombosis with ...
Posted by Michael Wonder on 10 Jun 2021
ATAGI update following weekly COVID-19 meeting – 9 June 2021
10 June 2021 - An update from the Australian Technical Advisory Group on Immunisation following their weekly meeting on 9 June ...