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RSS FeedPosted by Michael Wonder on 16 Jun 2022
Rhythm Pharmaceuticals announces FDA approval of Imcivree (setmelanotide) for use in patients with Bardet-Biedl syndrome
16 June 2022 - Approval based on Phase 3 trial results that demonstrated statistically significant reductions in weight and hunger in ...
Posted by Michael Wonder on 16 Jun 2022
Former FDA officials call for more transparency for drug approvals
15 June 2022 - The US FDA needs to take a more proactive approach in combatting misinformation and communicating decisions to ...
Posted by Michael Wonder on 16 Jun 2022
Kintara Therapeutics granted fast track designation from the FDA for VAL-083 for newly diagnosed glioblastoma
15 June 2022 - swire/ -- Kintara Therapeutics today announced that the United States FDA has granted fast track designation to ...
Posted by Michael Wonder on 15 Jun 2022
A first step towards best practice recommendations for the design and statistical analyses of pragmatic clinical trials: a modified Delphi approach
15 June 2022 - Pragmatic clinical trials are randomised trials implemented through routine clinical practice, where design parameters of traditional randomised ...
Posted by Michael Wonder on 15 Jun 2022
Start of rolling review for adapted Comirnaty COVID-19 vaccine
15 June 2022 - EMA has started a rolling review for a version of Comirnaty adapted to provide better protection ...
Posted by Michael Wonder on 15 Jun 2022
TGA approves Vyxeos
15 June 2022 - This marks the first TGA approval for Jazz Pharmaceuticals. ...
Posted by Michael Wonder on 15 Jun 2022
TGA approval of Kimmtrak
15 June 2022 - Tebentafusp is a bi-specific fusion protein. ...
Posted by Michael Wonder on 14 Jun 2022
FDA’s treatment of China developed drugs spurs demands for multiregional clinical trials
14 June 2022 - China’s ambition to become a leader in the biopharma industry has been clear in the last ...
Posted by Michael Wonder on 14 Jun 2022
FDA should step in to help spur AI/ML standards
13 June 2022 - The US FDA should support the burgeoning integration of artificial intelligence and machine learning in medical ...
Posted by Michael Wonder on 14 Jun 2022
Novavax COVID-19 vaccine Nuvaxovid provisionally registered in Australia as a booster in individuals aged 18 and over
13 June 2022 - In Australia, Nuvaxovid is the first protein-based COVID-19 vaccine registered for use as a booster regardless ...
Posted by Michael Wonder on 14 Jun 2022
Alnylam announces FDA approval of Amvuttra (vutrisiran), an RNAi therapeutic for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
13 June 2022 - First and only FDA approved treatment demonstrating reversal in neuropathy impairment with subcutaneous administration once every three ...
Posted by Michael Wonder on 13 Jun 2022
IP waiver for COVID vaccines misses the mark in vaccinating the world
14 June 2022 - Vaccinating the world remains a priority and proposals to weaken the intellectual property for COVID-19 vaccines ...
Posted by Michael Wonder on 13 Jun 2022
FDA accepts application for Merck’s Keytruda (pembrolizumab) as adjuvant therapy for stage IB (≥4 cm)-IIIA non-small-cell lung cancer following complete surgical resection
13 June 2022 - Acceptance based on results from the Phase 3 KEYNOTE-091 trial, the seventh positive pivotal trial evaluating ...
Posted by Michael Wonder on 13 Jun 2022
Amylyx Pharmaceuticals announces Health Canada approval of Albrioza for the treatment of ALS
13 June 2022 - Health Canada decision signifies the first global regulatory approval for Amylyx and the first new therapy for ...
Posted by Michael Wonder on 13 Jun 2022
BeiGene announces PDUFA goal date extension for U.S. sNDA for Brukinsa for the treatment of CLL/SLL
13 June 2022 - Following additional data submission to FDA demonstrating ORR superiority over ibrutinib as determined by IRC, PDUFA goal ...