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RSS FeedPosted by Michael Wonder on 17 Jan 2020
Fortress Biotech announces rare paediatric disease designation for CUTX-101 for the treatment of Menkes disease
16 January 2020 - Cyprium Therapeutics, a Fortress partner company, on track to begin submitting rolling new drug application for CUTX-101 ...
Posted by Michael Wonder on 17 Jan 2020
Ozempic approved in the US for CV risk reduction in people with type 2 diabetes and established CVD
16 January 2020 - Rybelsus label updated with additional information from the PIONEER 6 CV outcomes trial. ...
Posted by Michael Wonder on 16 Jan 2020
FDA grants fast track designation to Arena Pharmaceuticals' APD418 for development in decompensated heart failure patients
16 January 2020 - Arena Pharmaceuticals today announced that the U.S. FDA granted fast track designation for APD418, a β3-adrenergic ...
Posted by Michael Wonder on 16 Jan 2020
TG Therapeutics initiates rolling submission of new drug application to U.S. FDA for umbralisib as a treatment for patients with previously treated marginal zone lymphoma or follicular lymphoma
16 January 2020 - Completion of rolling submission for the MZL/FL NDA expected in 1H20. ...
Posted by Michael Wonder on 16 Jan 2020
Nektar issues statement regarding FDA Advisory Committee vote for oxycodegol
15 January 2020 - Nektar Therapeutics issued a statement today following a meeting of the FDA's Anesthetic and Analgesic Drug ...
Posted by Michael Wonder on 16 Jan 2020
U.S. targets drug pricing, no-poach deals for anti-trust action in 2020
15 January 2020 - Justice Department antitrust chief also promises decision on music licensing, criticizes states’ lawsuit against T-Mobile and Sprint. ...
Posted by Michael Wonder on 16 Jan 2020
Novavax granted fast track designation for NanoFlu in older adults
15 January 2020 - Novavax today announced that the U.S. FDA has granted fast track designation for NanoFlu, its recombinant quadrivalent ...
Posted by Michael Wonder on 15 Jan 2020
Clovis Oncology’s Rubraca (rucaparib) granted FDA priority review for advanced prostate cancer
15 January 2020 - FDA has assigned PDUFA date of 15 May 2020. ...
Posted by Michael Wonder on 15 Jan 2020
U.S. FDA accepts for priority review Bristol-Myers Squibb’s application for Opdivo (nivolumab) plus Yervoy (ipilimumab) in first-line non-small cell lung cancer
15 January 2020 - Application based on results from Part 1 of Phase 3 CheckMate-227 study. ...
Posted by Michael Wonder on 15 Jan 2020
Reform at the FDA—in need of reform
14 January 2020 - On 23 December 2016, the US FDA announced the approval of nusinersen, the first drug for the ...
Posted by Michael Wonder on 15 Jan 2020
FDA approval and regulation of pharmaceuticals, 1983-2018
14 January 2020 - How has the regulation of prescription drugs evolved from the 1980s to 2018, and what trends have ...
Posted by Michael Wonder on 14 Jan 2020
Roche aims to 'underwhelm' on SMA drug price to challenge rivals
14 January 2020 - Swiss drug maker Roche plans to price its oral spinal muscular atrophy drug risdiplam aggressively to challenge ...
Posted by Michael Wonder on 14 Jan 2020
FDA approves drugs faster than ever but relies on weaker evidence, researchers find
14 January 2020 - The FDA has gotten faster at approving new prescription drugs over the past four decades, but ...
Posted by Michael Wonder on 14 Jan 2020
Basket cases: how real-world testing for drugs approved based on basket trials might lead to false diagnoses, patient risks, and squandered resources
14 January 2020 - Basket trials, studies designed to assess the safety and efficacy of therapeutics targeted to a specific molecular ...
Posted by Michael Wonder on 14 Jan 2020
Chiasma announces FDA acceptance of Mycapssa new drug application resubmission
13 January 2020 - FDA sets PDUFA date of 26 June 2020. ...