BioMarin explores pricing experimental gene therapy at $2 million to $3 million

16 January 2020 - Valrox would be first gene therapy approved in U.S. for inherited type of haemophilia. ...

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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 ...

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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. ...

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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 ...

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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. ...

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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 ...

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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. ...

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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 ...

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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. ...

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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. ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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