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BioWorld - Wednesday, February 1, 2023
Home » Topics » Regulatory

Regulatory
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FDA grants accelerated approval to Rubraca for BRCA-mutated metastatic CRPC

May 18, 2020
No Comments

Opdivo + Yervoy approved in U.S. for first-line metastatic NSCLC with PD-L1 expression >= 1%

May 18, 2020
No Comments

FDA approves Pomalyst for AIDS-related and HIV-negative Kaposi sarcoma

May 18, 2020
No Comments

Deciphera’s Qinlock wins early approval for rare cancer

May 15, 2020
By Michael Fitzhugh
No Comments
Only hours after Blueprint Medicines Corp. disclosed an FDA complete response letter for avapritinib in fourth-line gastrointestinal stromal tumor (GIST), Deciphera Pharmaceuticals Inc.’s kinase inhibitor, ripretinib, won the agency’s approval for the same indication, well ahead of its Aug. 13 PDUFA date.
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Toraymyxin (PMX) product image

Health Canada approves PMX treatment for sickest COVID-19 patients

May 15, 2020
By David Godkin
No Comments
TORONTO – The Toraymyxin (PMX) hemoperfusion cartridge developed by Toronto’s Spectral Medical Inc. and used successfully to treat patients during the avian and swine flu pandemics is being eyed to help COVID-19 patients in Canada. Specifically, an emergency interim order from Health Canada expands its use to include treatment of COVID-19 patients with high levels of endotoxin in their blood and in acute respiratory failure.
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Myrian XP-Lung product suite

Intrasense obtains CE mark for its CT scanner protocol designed for COVID-19

May 15, 2020
By Bernard Banga
No Comments
PARIS – Intrasense SA, of Montpellier, France, has gained CE marking for its CT scanner reading protocol designed for COVID-19. “This major step forward, coming at the same time as U.S. FDA clearance, will allow a true mass rollout of our Myrian XP-Lung system designed for COVID-19,” Nicolas Reymond, CEO of Intrasense, told BioWorld.
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Biopharma research illustration
Regulatory data

April brings five NME approvals, 11 fast tracks; 25% focused on COVID-19

May 15, 2020
By Karen Carey
No Comments
While a significant number of clinical trial delays occurred during the month of April, it was business as usual from a regulatory standpoint for companies with late-stage therapies ready for the market and for those targeting underserved patient populations.
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Regulatory front for May 15, 2020

May 15, 2020
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The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Allergan, Ideal Implant.
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Regulatory actions for May 15, 2020

May 15, 2020
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Balt, Caredx, Hologic.
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Approved stamp

Zai Lab and Novocure score the first China approval for glioblastoma in 15 years

May 15, 2020
By David Ho
No Comments
HONG KONG –Shanghai-based Zai Lab Ltd. has won an approval for the first innovative treatment for glioblastoma approved by China in more than 15 years, with the National Medical Products Administration’s (NMPA) nod for Optune in combination with temozolomide for use in patients with newly diagnosed glioblastoma (GBM), and also as a monotherapy for the treatment of patients with recurrent GBM.
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