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RSS FeedPosted by Michael Wonder on 14 Apr 2021
TGA accepts Telix’s prostate cancer imaging product submission and commences priority evaluation process
14 April 2021 - Telix is pleased to announce that the TGA has accepted the Company’s submission for the registration ...
Posted by Michael Wonder on 14 Apr 2021
AstraZeneca’s COVID-19 vaccine: EMA to provide further context on risk of very rare blood clots with low blood platelets
14 April 2021 - EMA continues to monitor very rare blood clots with low blood platelets that occurred after vaccination ...
Posted by Michael Wonder on 14 Apr 2021
COVID-19 vaccine Janssen: assessment of very rare cases of unusual blood clots with low platelets continues
14 April 2021 - As announced last week, EMA’s safety committee (PRAC) is reviewing very rare cases of unusual blood clots ...
Posted by Michael Wonder on 14 Apr 2021
Moleculin awarded new rare paediatric disease designation from U.S. FDA for WP1066 for the treatment of ependymoma
14 April 2021 - Moleculin Biotech announced today that the U.S. FDA has granted rare paediatric disease designation to its ...
Posted by Michael Wonder on 14 Apr 2021
TGA grants provisional determination to GSK for COVID-19 monoclonal antibody treatment - sotrovimab
14 April 2021 - The TGA has granted a provisional determination to GSK in relation to the monoclonal antibody treatment, ...
Posted by Michael Wonder on 14 Apr 2021
Batch release assessment of COVID-19 vaccines
14 April 2021 - The Therapeutic Goods Administration ensures there is an independent quality assessment of every batch of vaccine supplied ...
Posted by Michael Wonder on 13 Apr 2021
U.S. FDA to scrutinise vaccine design behind COVID-19 shots linked to blood clots
13 April 2021 - With two COVID-19 vaccines now under scrutiny for possible links to very rare cases of blood ...
Posted by Michael Wonder on 13 Apr 2021
Atossa Therapeutics announces ovarian cancer patient has begun treatment with oral endoxifen under FDA’s Expanded Access Pathway
13 April 2021 - Atossa Therapeutics today announced that an ovarian cancer patient has begun treatment with Atossa’s proprietary oral endoxifen. ...
Posted by Michael Wonder on 13 Apr 2021
Did Australia get it right on AstraZeneca?
14 April 2021 - The almost-total absence of criticism for Australia’s decision to preference Pfizer’s vaccine over AstraZeneca’s for people ...
Posted by Michael Wonder on 13 Apr 2021
FDA grants accelerated approval to sacituzumab govitecan for advanced urothelial cancer
13 April 2021 - Today the Food and Drug Administration granted accelerated approval to sacituzumab govitecan (Trodelvy, Immunomedics) for patients ...
Posted by Michael Wonder on 13 Apr 2021
vTv Therapeutics receives FDA breakthrough therapy designation for TTP399 for the treatment of type 1 diabetes
13 April 2021 - Designation offers potential for expedited development pathway and reinforces TTP399’s potential to provide a substantial clinical benefit. ...
Posted by Michael Wonder on 13 Apr 2021
Joint CDC and FDA statement on Johnson & Johnson COVID-19 vaccine
13 April 2021 - The following statement is attributed to Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation ...
Posted by Michael Wonder on 13 Apr 2021
Avenue Therapeutics announces that the FDA is still reviewing its NDA resubmission for IV tramadol
13 April 2021 - The FDA has not provided a decision regarding the new drug application. ...
Posted by Michael Wonder on 13 Apr 2021
Adamis Pharmaceuticals provides an update on Zimhi
12 April 2021 - Adamis Pharmaceuticals today provided an update on the status of the company’s new drug application relating ...
Posted by Michael Wonder on 12 Apr 2021
Cavazzoni to take over influential spot atop FDA drug center
12 April 2021 - Patrizia Cavazzoni has been named the permanent leader of the FDA’s Center for Drug Evaluation and ...