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RSS FeedPosted by Michael Wonder on 07 Jun 2021
Alexion announces FDA approval of Ultomiris (ravulizumab-cwvz) for children and adolescents with paroxysmal nocturnal haemoglobinuria
7 June 2021 - Approval based on interim results from Phase 3 study showing Ultomiris demonstrated complete terminal complement inhibition through ...
Posted by Michael Wonder on 07 Jun 2021
Proposed refinements to the regulation of personalised medical devices
7 June 2021 - Regulatory changes introducing a new framework for the regulation of personalised medical devices commenced on 25 ...
Posted by Michael Wonder on 07 Jun 2021
FDA grants accelerated approval for Alzheimer’s drug
7 June 2021 - Today, the U.S. FDA approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 ...
Posted by Michael Wonder on 07 Jun 2021
Innovative regenerative medicine therapies – patient safety comes first
3 June 2021 - The U.S. FDA continues to facilitate the development and availability of innovative medical products, such as regenerative ...
Posted by Michael Wonder on 07 Jun 2021
After repeated losses in the U.S., Catalyst wins a victory in Canada over a rare disease drug
3 June 2021 - In an unexpected move, Canada’s Federal Court quashed the approval of a rare disease drug after ...
Posted by Michael Wonder on 07 Jun 2021
EMA raises awareness of clinical care recommendations to manage suspected thrombosis with thrombocytopenia syndrome
7 June 2021 - EMA’s COVID-19 taskforce (COVID-ETF) is advising health care professionals in the EU to consider recommendations by learned ...
Posted by Michael Wonder on 07 Jun 2021
TGA investigating Pfizer jabs for children over 12
7 June 2021 - Australia’s medical regulator is considering allowing children over the age of 12 to be vaccinated with ...
Posted by Michael Wonder on 07 Jun 2021
New regulatory arrangements support businesses and health care professionals to communicate and incentivise COVID-19 vaccination
7 June 2021 - The TGA has implemented arrangements to facilitate the communication of information about approved COVID-19 vaccines. ...
Posted by Michael Wonder on 06 Jun 2021
The parents hoped an existing drug might keep their kids from having seizures. Then they saw the price.
3 June 2021 - When Amber Freed heard in 2020 that a drug might help save her young child from ...
Posted by Michael Wonder on 06 Jun 2021
FDA’s decision on Biogen Alzheimer’s drug will be a watershed moment for the agency — and the biotech industry
4 June 2021 - In the coming days the FDA will make one of its most important — and controversial — ...
Posted by Michael Wonder on 05 Jun 2021
Alzheimer’s drug poses a dilemma for the FDA
5 June 2021 - If the agency approves it, aducanumab would be the first new Alzheimer’s treatment since 2003. ...
Posted by Michael Wonder on 05 Jun 2021
Newly approved obesity drug Wegovy holds promise, but faces reimbursement challenges
5 June 2021 - On 4 June, the FDA approved Novo Nordisk’s obesity drug Wegovy (semaglutide), a glucagon-like peptide 1 receptor ...
Posted by Michael Wonder on 05 Jun 2021
Chimerix receives U.S. FDA approval for Tembexa (brincidofovir) for the treatment of smallpox
4 June 2021 - First smallpox anti-viral approved for all age groups, including infants, and patients who have difficulty swallowing. ...
Posted by Michael Wonder on 05 Jun 2021
FDA approves new drug treatment for chronic weight management, first since 2014
4 June 2021 - Today, the U.S. FDA approved Wegovy (semaglutide) injection (2.4 mg once weekly) for chronic weight management in ...
Posted by Michael Wonder on 04 Jun 2021
FDA approves first treatment for patients with plasminogen deficiency, a rare genetic disorder
4 June 2021 - Today, the U.S. FDA approved Ryplazim (plasminogen, human-tmvh) for the treatment of patients with plasminogen deficiency type ...