Search Results for “FDA” – Page 175 – media

4 causes of failure for medical devices

Materials are one of the most common causes of failure in medical devices, especially for plastic. Records show that material failure is responsible for 30 to 40 percent of all FDA recalls on medical devices.
- Source: multibriefs
- 559
- February 12, 2018
Market Views medical device
Stanford spin-out Zenflow raises $31M to join the megamarket for enlarged prostate

A San Francisco, California-based medical device startup, Zenflow, has announced a $31.4 million Series A financing round to further its minimally-invasive approach to treating benign prostatic hyperplasia (BPH) or enlarged prostate.
- Source: MedCityNews
- 714
- February 11, 2018
FDA financing Market Views prostate
Another Day, Another Breakthrough Tag for GlaxoSmithKline’s Bexsero

GlaxoSmithKline’s meningitis B vaccine Bexsero is in a class all by itself when it comes to snagging the Breakthrough Therapy Designation from the U.S. Food and Drug Administration(FDA).
- Source: biospace
- 573
- February 9, 2018
Bexsero FDA GSK meningitis B vaccine
U.S. Food and Drug Administration Approves Gilead’s Biktarvy®

Gilead Sciences, Inc. on February 7 announced that the U.S. Food and Drug Administration (FDA) has approved Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection.
- Source: Finchannel
- 782
- February 9, 2018
Biktarvy HIV-1 New Approvals STR
Pfizer vs J&J– Researchers are duking it out for the championship title in nonmetastatic prostate cancer

Pfizer $PFE and J&J $JNJ have come down to the wire with pivotal data on nonmetastatic prostate cancer. And there are billions of dollars in revenue on the line here.
- Source: Endpts
- 451
- February 7, 2018
Market Views prostate cancer
Why AstraZeneca’s New Drug Strategy Seems to be Bearing Fruit

Pharma giant AstraZeneca has seen a fourfold increase in research productivity following a narrowing of disease focus and cuts in laboratory and staff over the past seven years, Reutersreported Thursday.
- Source: china-pharmacy
- 484
- February 7, 2018
AstraZeneca New Drug Strategy
Drug Safety Communication – Boxed Warning Added To Highlight Correct Dosing

FDA is warning that the liver disease medicine Ocaliva (obeticholic acid) has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis (PBC), a rare chronic liver disease, increasing the risk of serious liver injury. To ensure correct dosing and reduce the risk of liver problems, FDA is clarifying the current recommendations for screening, dosing, monitoring, and managing PBC patients with moderate to severe liver disease taking Ocaliva. FDA is adding a new Boxed Warning, FDA’s most prominent warning, to highlight this information in the prescribing information of the drug label. FDA is also requiring a Medication Guide for patients to inform them about this issue.
- Source: fda
- 560
- February 6, 2018
Boxed Warning FDA liver disease Ocaliva PBC
Insightec closes $150m Series E

HAIFA, Israel and MIAMI, Florida – INSIGHTEC®, a commercial-stage medical technology company revolutionizing surgery with incisionless MRI-guided focused ultrasound (MRgFUS) announced today the closing of a $150 million Series E private equity investment round. Koch Disruptive Technologies (KDT), a subsidiary of Koch Industries, focused on finding and funding innovative and emerging companies, led the round with a $100 million investment.
- Source: drugdu
- 510
- February 6, 2018
Market Views MRgFUS non-invasive treatments
Ultrasound tech genetically controls cells to kill cancer new study finds

Researchers say the approach breaks new ground in treating cancer non-invasively and with unprecedented precision.
- Source: Healthcare IT news
- 577
- February 6, 2018
cancer CAR–T immunotherapy Researches
Breakthrough status for Roche’s autism drug

Roche’s balovaptan has picked up a Breakthrough Therapy Designation in the US for its potential as a treatment for people with autism spectrum disorder (ASD), potentially placing the drug on a faster path to market.
- Source: pharmatimes
- 614
- February 5, 2018
ASD balovaptan New Approvals Roche

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