Kratom is not a cure for opioid addiction, FDA says in cracking down on illegal marketing




 

The FDA cited examples of two companies claiming that kratom can treat addiction, but the FDA hasn't approved the products for such uses.

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Roche test receives FDA emergency use approval for COVID-19 patients
Roche test receives FDA emergency use approval for COVID-19 patients
  • US
  • 2020-06-04 05:17:37Z

Drugmaker Roche has received emergency use authorisation from the U.S. Food and Drug Administration for its Elecsys IL-6 test to help identify severe inflammatory response in patients with confirmed COVID-19, it said on Thursday. The test can be used to help identify coronavirus patients who could be at high risk of intubation with mechanical ventilation, helping doctors decide early on if ventilation could be required, Roche said. Roche is testing its arthritis drug Actemra in patients with coronavirus-linked pneumonia, joining other pharmaceutical companies seeking to re-purpose existing medicines to fight the epidemic.

Coronavirus (COVID-19) Update: Daily Roundup
Coronavirus (COVID-19) Update: Daily Roundup

Coronavirus (COVID-19) Update: Daily RoundupPR NewswireSILVER SPRING, Md., June 2, 2020SILVER SPRING, Md.

'You could see the train wreck coming': Inexperienced, dubious companies among many aiming to cash in on coronavirus antibody tests

Lax FDA oversight spurred a nascent industry of antibody test makers, with companies jockeying to cash in, a USA TODAY investigation found.

AbbVie Seeks Rinvoq Approval For Psoriatic Arthritis In US, Europe
AbbVie Seeks Rinvoq Approval For Psoriatic Arthritis In US, Europe

Drugmaker AbbVie (ABBV) has announced that it has submitted applications for a new indication for Rinvoq (upadacitinib; 15 mg, once daily) for the treatment of adult patients with active psoriatic arthritis.The applications were submitted to both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA)."Psoriatic arthritis is a complex heterogeneous disease with manifestations across multiple domains, including joints and skin, causing daily pain, fatigue and stiffness," said Michael Severino of AbbVie. "We look forward to working with regulatory authorities and hope to bring RINVOQ to people living with this debilitating disease as quickly as possible."The...

Aveo
Aveo's Tivozanib Gets FDA Nod For New Drug Application To Treat Kidney Cancer

Aveo Oncology (AVEO) announced that the U.S. Food and Drug Administration approved the New Drug Application (NDA) for its tivozanib used for the treatment of kidney cancer.Tivozanib is the company's next-generation vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI) targeted for the treatment of relapsed or refractory renal cell carcinoma (RCC). The FDA has assigned the application standard review and a Prescription Drug User Fee Act target deadline date of March 31, 2021."The acceptance of our NDA filing marks yet another important milestone for AVEO, as we pursue our goal of providing RCC patients whose disease has relapsed or become refractory to multiple...

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