Food and Drug Administration

WONTECH Receives FDA Clearance for 'SANDRO DUAL'

Thursday, April 2, 2020 - 1:13am

SANDRO DUAL has already attracted great attention as it was launched in Korea Nd:YAG & Alexandrite based lasers mounted on one device.

Key Points: 
  • SANDRO DUAL has already attracted great attention as it was launched in Korea Nd:YAG & Alexandrite based lasers mounted on one device.
  • Seung-woo Song, Chief of the U.S branch of WONTECH said, "We were delighted to receive FDA clearance with the effectiveness and stability.
  • With this clearance, we will accelerate into global markets all around the world, including the US and Europe."
  • WONTECH is a rapidly growing provider in the world of laser and light-based aesthetic devices.

2020 COVID 19 Drug Pipeline Report- Current Status, Phase, Companies, Pre-Clinical And Clinical Drugs

Wednesday, April 1, 2020 - 5:31pm

NEW YORK, April 1, 2020 /PRNewswire/ --The 2020 COVID-19 pipeline report presents a comprehensive overview of the research and development of COVID drug candidates.

Key Points: 
  • NEW YORK, April 1, 2020 /PRNewswire/ --The 2020 COVID-19 pipeline report presents a comprehensive overview of the research and development of COVID drug candidates.
  • As of March 2020, the COVID-19 pipeline remains robust with over 30 therapeutic candidates under development.
  • An increasing number of companies are actively participating in the development of treatment and vaccination against novel corona virus infected COVID 19.
  • The report provides complete details of pipeline drugs including the development phase, companies involved, clinical trial developments, and other details.

Global Orphan Drug Clinical Trials, Patent & Guidelines Insight 2026

Wednesday, April 1, 2020 - 7:05pm

NEW YORK, April 1, 2020 /PRNewswire/ --"Global Orphan Drug Clinical Trials, Patent & Guidelines Insight 2026" Report Highlights:

Key Points: 
  • NEW YORK, April 1, 2020 /PRNewswire/ --"Global Orphan Drug Clinical Trials, Patent & Guidelines Insight 2026" Report Highlights:
    Global Orphan Drug Market Opportunity: US$ 300 Billion
    US Dominates Global Orphan Drug Market: 50% Market Share
    US Orphan Drug Opportunity To Surpass: US$ 150 Billion
    Global Orphan Drug Clinical Insight: More Than 900 Drugs
    Clinical Insight on Marketed Orphan Drugs: More Than 400 Drugs
    Oncology To Dominate Orphan Drug Development: 35% Share
    The research report "Global Orphan Drug Clinical Trials, Patent & Guidelines Insight 2026" discusses about the recent trends and opportunities that the orphan drug market has brought into the pharmaceutical sector.
  • The research report shares the information related to drugs that have been successfully designated as orphan drugs by respective approval authorities, with an exclusive insight on clinical uniqueness and patent information.
  • The FDA & EMA have designated a drug as orphan drug for which the cases in the US are less than 0.2 Million and not more than 5 in 10,000 people across the EU.
  • The structured regulatory and policy framework favoring the research and development of orphan designated drugs resulted in the much needed thrust for the development of global orphan drug market.

Forward Announces the Availability of COVID-19 Rapid Testing

Wednesday, April 1, 2020 - 6:04pm

Forward , the preventive primary care practice combining top rated doctors and advanced medical technology, today announces the availability of rapid blood testing to screen for COVID-19 at clinics and drive-through sites nationwide.

Key Points: 
  • Forward , the preventive primary care practice combining top rated doctors and advanced medical technology, today announces the availability of rapid blood testing to screen for COVID-19 at clinics and drive-through sites nationwide.
  • Per FDA guidance, Forward is not using these rapid serological tests as a sole means of understanding COVID-19 infection status.
  • Forward strives to offer the best possible options, and offering serological testing helps Forward stay proactive in the care of its members.
  • With the expansion into rapid testing, Forward furthers its mission of providing the best quality health care.

Global Wounds Clinical Trials Review - H1, 2020 - ResearchAndMarkets.com

Wednesday, April 1, 2020 - 4:37pm

The "Wounds Global Clinical Trials Review, H1, 2020" clinical trials has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Wounds Global Clinical Trials Review, H1, 2020" clinical trials has been added to ResearchAndMarkets.com's offering.
  • This clinical trial report, Wounds Global Clinical Trials Review, H1, 2020" provides an overview of Wounds Clinical trials scenario.
  • This report provides top line data relating to the clinical trials on Wounds.
  • Clinical trials are collated from 80+ different clinical trial registries, conferences, journals, news etc across the globe.

Global Oral Cancer Clinical Trials Review - H1, 2020 - ResearchAndMarkets.com

Wednesday, April 1, 2020 - 4:30pm

The "Oral Cancer Global Clinical Trials Review, H1, 2020" clinical trials has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Oral Cancer Global Clinical Trials Review, H1, 2020" clinical trials has been added to ResearchAndMarkets.com's offering.
  • This clinical trial report, Oral Cancer Global Clinical Trials Review, H1, 2020" provides an overview of Oral Cancer Clinical trials scenario.
  • This report provides top line data relating to the clinical trials on Oral Cancer.
  • Clinical trials are collated from 80+ different clinical trial registries, conferences, journals, news etc across the globe.

Acasti Pharma Submits FDA Meeting Request on Schedule, and FDA Meeting Expected in the Second Half of June

Wednesday, April 1, 2020 - 1:30pm

The meeting is intended to discuss TRILOGY 1 data, and gain alignment with the FDA on the interpretation of the results.

Key Points: 
  • The meeting is intended to discuss TRILOGY 1 data, and gain alignment with the FDA on the interpretation of the results.
  • As previously noted, upon submission of the meeting request, Acasti anticipates meeting with the FDA in the second half of June.
  • We believe the FDA meeting will provide essential guidance as we prepare to unblind and conduct the topline analysis of the TRILOGY 2 data.
  • We look forward to meeting with the FDA and providing further updates as they unfold.

Soleo Health Selected by Grifols as Limited Drug Distribution Partner for XEMBIFY®

Wednesday, April 1, 2020 - 4:21pm

XEMBIFY is for subcutaneous injection only and was approved by the U.S. Food & Drug Administration (FDA) in July 2019.

Key Points: 
  • XEMBIFY is for subcutaneous injection only and was approved by the U.S. Food & Drug Administration (FDA) in July 2019.
  • Soleo Health is recognized nationally for its ability to gather disease-specific, drug-specific and patient-specific data for patients under its clinical care through SoleMetrics.
  • Our current portfolio of many limited drug distribution relationships speaks directly to this, said Craig Vollmer, chief commercial officer at Soleo Health.
  • Barbara Prosser, Soleo Healths vice president, health outcomes and research, said, The real-world data Soleo Health collects and delivers offers drug manufacturers a keen understanding and in-depth details of patients under our care.

Daré Bioscience Receives Third Notice of Award from National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development for the Development of Ovaprene®

Wednesday, April 1, 2020 - 1:00pm

This award notice is timely, as we plan to file an Investigational Device Exemption application with the FDA to support the ongoing development of Ovaprene later this year.

Key Points: 
  • This award notice is timely, as we plan to file an Investigational Device Exemption application with the FDA to support the ongoing development of Ovaprene later this year.
  • Dar plans to continue to pursue non-dilutive funding opportunities to support the further development of its product candidates.
  • This press release discusses research supported by the Eunice Kennedy Shriver National Institute of Child Health & Human Development of theNational Institutes of Healthunder Award Number R44HD095724.
  • Dar Bioscience is a clinical-stage biopharmaceutical company committed to the advancement of innovative products for womens health.

Brain Scientific Launches Online Store To Sell Sanitized EEG Products

Wednesday, April 1, 2020 - 12:00pm

NEW YORK, April 01, 2020 (GLOBE NEWSWIRE) -- Brain Scientific Inc. (OTC:BRSF) (Brain Scientific or Company), a medical device and technology company offering products and solutions related to the brain including neurology, AI and machine learning, today announced the launch of their online store to sell FDA-cleared NeuroCap and NeuroEEG.

Key Points: 
  • NEW YORK, April 01, 2020 (GLOBE NEWSWIRE) -- Brain Scientific Inc. (OTC:BRSF) (Brain Scientific or Company), a medical device and technology company offering products and solutions related to the brain including neurology, AI and machine learning, today announced the launch of their online store to sell FDA-cleared NeuroCap and NeuroEEG.
  • During administration, traditional EEG procedure involve a scrub of the skin, which can expose EEG electrodes to blood and other disease-carrying bodily fluids.
  • With the recent COVID-19 outbreak, we have seen the importance of delivering sanitized healthcare products to not only the clinical setting, but also the general outpatient environment, stated Irina Nazarova, Marketing Director of Brain Scientific.
  • We launched our online store to meet the high demand for sterile hospital equipment and make our sterilized FDA-cleared EEG products accessible to practitioners.