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RSS FeedPosted by Michael Wonder on 14 Jul 2021
FDA chief Janet Woodcock acknowledges agency may have misstepped in process leading up to Alzheimer’s drug approval
14 July 2021 - Acting FDA Commissioner Janet Woodcock acknowledged on Wednesday her agency may have misstepped in its handling ...
Posted by Michael Wonder on 14 Jul 2021
Prescription medicines: applications under evaluation (July 2021 update)
14 July 2021 - The TGA has updated its list of applications for new medicines/vaccines or new uses for existing medicines/vaccines ...
Posted by Michael Wonder on 14 Jul 2021
FDA grants Alkeus Pharmaceuticals breakthrough therapy designation for ALK-001 (C20-D3-vitamin A) for the treatment of Stargardt disease
14 July 2021 - Only drug to receive breakthrough therapy designation for Stargardt disease. ...
Posted by Michael Wonder on 14 Jul 2021
ASP3772 receives FDA breakthrough therapy designation
12 July 2021 - The U.S. FDA has granted breakthrough therapy designation for ASP3772 for the prevention of pneumonia and invasive ...
Posted by Michael Wonder on 14 Jul 2021
Harvard doctor urges FDA reforms after Biogen Alzheimer nod
13 July 2021 - Curtail biomarker use for clearance, Kesselheim writes in JAMA. ...
Posted by Michael Wonder on 13 Jul 2021
Biden in standoff with Democratic senators over who should lead FDA
13 July 2021 - Nearly six months into a presidency fully engulfed in a battle against a global pandemic, President Joe ...
Posted by Michael Wonder on 13 Jul 2021
European efforts to assess Russia’s Sputnik V vaccine stymied by data gaps
13 July 2021 - The developers of Russia’s Sputnik V coronavirus vaccine have repeatedly failed to provide data that regulators ...
Posted by Michael Wonder on 13 Jul 2021
Stryker announces the FDA clearance of the first biodegradable subacromial balloon spacer, filling a gap in the shoulder continuum of care
13 July 2021 - The InSpace balloon implant is a breakthrough solution for arthroscopic treatment of massive irreparable rotator cuff tears ...
Posted by Michael Wonder on 13 Jul 2021
ATAGI statement on use of COVID-19 vaccines in an outbreak setting
13 July 2021 - A statement from the Australian Technical Advisory Group on Immunisation (ATAGI) on the use of COVID-19 vaccines ...
Posted by Michael Wonder on 13 Jul 2021
Powerful House Democrats demand documents from Biogen about co-ordination with FDA on new Alzheimer’s drug
12 July 2021 - Two powerful House Democrats on Monday demanded documents from Biogen about the approval process, marketing, and ...
Posted by Michael Wonder on 12 Jul 2021
FDA to announce new warning on J&J COVID vaccine related to a rare auto-immune disorder, report says
12 July 2021 - About 100 preliminary reports of Guillain-Barre syndrome have been detected after 12.8 million doses of the J&J ...
Posted by Michael Wonder on 12 Jul 2021
FDA approves daratumumab and hyaluronidase-fihj with pomalidomide and dexamethasone for multiple myeloma
12 July 2021 - On 9 July 2021, the FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech) in combination ...
Posted by Michael Wonder on 12 Jul 2021
FDA’s expansive Alzheimer’s drug approval surprised even top agency officials
9 July 2021 - The FDA’s contentious decision to approve a new Alzheimer’s drug for every single patient with the ...
Posted by Michael Wonder on 12 Jul 2021
Experts warn full FDA COVID-19 vaccine approval is no quick fix for hesitancy
12 July 2021 - The FDA issuing full approval for two COVID-19 vaccines might not be the game changer it’s ...
Posted by Michael Wonder on 11 Jul 2021
EMA advises against use of COVID-19 vaccine Janssen in people with history of capillary leak syndrome
9 July 2021 - EMA’s safety committee has recommended that people who have previously had capillary leak syndrome must not be ...