FDA – Page 3 – media

FDA Approves Healthy.io Smartphone Camera-based Home Urine Analysis

Healthy.io, of Israel, gains FDA 510(k) approval for Dip.io, it's domestic urinalysis kit that transforms a smartphone into a clinical-standard diagnostic machine. It is the first and only smartphone-based urine analysis to be cleared as a Class 2 device.
- Source: MobiHealthNews
- 599
- July 27, 2018
FDA mHealth New Approvals
Valsartan Based Drugs Recalled by FDA

At the beginning of this month, the U.S. Food and Drug Administration (FDA) announced to withdraw drugs containing valsartan, which treat high blood pressure and heart failure. The drugs were withdrawn due to the presence of N-nitrosodimethylamine (NDMA), which might lead to cancer.
- Source: HealthLine
- 880
- July 26, 2018
blood pressure cancer FDA heart failure Policies
Bayer Announces the end of Essure Sales in the US

Bayer announced on last Friday that it would stop the sales of its Essure birth control system in the United States by the end of this year due to a steady decline in its sales making the product no longer justifiable. Bayer insisted that its decision to discontinue Essure sales is only for business reasons and not for any safety or efficacy concerns.
- Source: MDDI Online
- 652
- July 25, 2018
Company Insight contraceptive device FDA
Mersana’s Lead Cancer ADC Held Up by FDA for Patient’s Death

The FDA held up Mersana’s top antibody-drug conjugate (ADC), XMT-1522 over safety issues following a patient’s death in phase 1 trial, causing a descent in the company’s shares.
- Source: FierceBiotech
- 209
- July 25, 2018
cancer Clinical Trial FDA
Karyopharm Seeks FDA Approval for Selinexor Drug for Multiple Myeloma

The Newton Massachusetts-based company, Karyopharm Therapeutics, who developed a new class of drugs to treat multiple myeloma, is in the process of submitting a new drug application to the FDA for their selinexor drug.
- Source: MedCityNews
- 419
- July 24, 2018
cancer CAR-T therapies FDA New Approvals
AbbVie Investors Need not Abandon Ship yet

After watching Scott Gottlieb, M.D. of the FDA comments regarding the rebate rule changes and a warning tweet on biosimilars, AbbVie investors are bailing out. But the industry watchers claim that they don’t need to be.
- Source: FiercePharma
- 1,101
- July 24, 2018
AbbVie biopharmaceutical FDA Market Views
Viz.ai Develops AI Software to Detect Stroke

Artificial intelligence based company Viz.ai, currently developing software for the detection of urgent stroke cases, has recently raised $21 million in venture capital to develop its portfolio.
- Source: FierceBiotech
- 827
- July 20, 2018
AI Company Insight digital health FDA
Siga Technologies Wins FDA Approval for Tecovirimat to Treat Smallpox

A New York-based company named Siga Technologies has won FDA approval for its oral formulation of tecovirimat, used to treat smallpox, in case there occurs an outbreak.
- Source: DrugDeliveryBusiness
- 738
- July 17, 2018
FDA New Approvals smallpox
FDA backs GSK’s Tafenoquine for Malaria Cure

Sanction of a single 300mg dose of GlaxoSmithKline’s tafenoquine in patients 16 years and above for the "radical cure" of malaria was advocated by an FDA advisory committee on finding significant evidence for its efficacy and safety.
- Source: MedPageToday
- 4,429
- July 16, 2018
FDA GSK malaria New Approvals
FDA Clearance for Echonous Vein Ultrasound

EchoNous announced that it has been granted FDA 510(k) clearance for its EchoNous Vein ultrasound device which could improve peripheral IV catheter placements. This system could provide real-time clear mages of superficial and deeper veins.
- Source: The Verge
- 5,614
- July 16, 2018
FDA medical device New Approvals ultrasound

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