Latest fda news

fda

BREAKING: FDA issues emergency authorization for first coronavirus antigen test

By dennismichaellynch.com
Published On :: Sat, 09 May 2020 17:05:45 +0000

The DML News App offers the best in news reporting.

The post BREAKING: FDA issues emergency authorization for first coronavirus antigen test appeared first on Dennis Michael Lynch.

Full Article

News Feed Powered by DMLNewsApp.com

fda

FDA approves first at-home saliva collection test for coronavirus

By www.eurekalert.org
Published On :: Fri, 08 May 2020 00:00:00 EDT

(Rutgers University) Rutgers' RUCDR Infinite Biologics received an amended emergency use authorization from the FDA late Thursday for the first SARS-CoV-2 coronavirus test that will allow people to collect their own saliva at home and send to a lab for results. The decision follows the FDA's recent emergency approval to RUCDR Infinite Biologics for the first saliva-based test, which involves health care workers collecting saliva from individuals at testing sites.

Full Article

fda

SNMMI Hosts FDA Workshop

By jnm.snmjournals.org
Published On :: 2020-04-01T06:00:28-07:00

Full Article

fda

FDA approves first at-home saliva test for COVID-19

By www.upi.com
Published On :: Sat, 09 May 2020 03:37:06 -0400

The first COVID-19 test using saliva samples that patients collect at home has been approved by the U.S. Food and Drug Administration.

Full Article

fda

FDA approves combination ibuprofen-acetaminophen drug for U.S.

By www.ada.org
Published On :: Mon, 02 Mar 2020 13:59:00 -0600

The Food and Drug Administration has approved the first over-the-counter ibuprofen and acetaminophen combination drug for the U.S.

Full Article

fda

FDA alerts health care providers of EpiPen auto-injector errors

By www.ada.org
Published On :: Thu, 26 Mar 2020 14:04:00 -0500

The U.S. Food and Drug Administration announced March 24 that it is alerting health care professionals, patients and caregivers of EpiPen autoinjector errors related to device malfunctions and user administration.

Full Article

fda

FDA approves remdesivir to treat COVID-19

By www.upi.com
Published On :: Fri, 01 May 2020 18:07:36 -0400

The U.S. Food and Drug Administration on Friday granted emergency use authorization to the antiviral remdesivir to treat COVID-19.

Full Article

fda

FDA grants emergency approval for first at-home saliva-based coronavirus test

By www.news-medical.net
Published On :: Fri, 08 May 2020 21:06:37 -0400

Rutgers' RUCDR Infinite Biologics received an amended emergency use authorization from the FDA late Thursday for the first SARS-CoV-2 coronavirus test that will allow people to collect their own saliva at home and send to a lab for results.

Full Article

fda

Identification of antiviral drug candidates against SARS-CoV-2 from FDA-approved drugs [Antiviral Agents]

By aac.asm.org
Published On :: 2020-05-04T08:49:24-07:00

Drug repositioning is the only feasible option to address the COVID-19 global challenge immediately. We screened a panel of 48 FDA-approved drugs against SARS-CoV-2 which were pre-selected by an assay of SARS-CoV and identified 24 potential antiviral drug candidates against SARS-CoV-2 infection. Some drug candidates showed very low micromolar IC50s and in particular, two FDA-approved drugs - niclosamide and ciclesonide – were notable in some respects.

Full Article

fda

FDA Bans Use of Shock Therapy at School for Students With Special Needs

By feedproxy.google.com
Published On :: Thu, 05 Mar 2020 00:00:00 +0000

The FDA estimates that between 45 and 50 students at a Massachusetts school for students with autism, emotional disturbances, and intellectual disabilities are subjected to electrical shocks through electrodes attached to their skin.

Full Article

Specialeducation

fda

FDA Approves CRISPR-Based Coronavirus Test

By www.extremetech.com
Published On :: Fri, 08 May 2020 17:05:42 GMT

Source: www.extremetech.com - Friday, May 08, 2020
Public health officials universally agree that the world needs much more coronavirus testing before we can safely ease current lock-down restrictions. Even at the low end, experts say we’ll need to do hundreds of thousands more daily tests, but the equipment and resources to make that happen are in short supply. An MIT spin-off company called Sherlock Biosciences has gotten FDA approval to begin using its CRISPR-based COVID-19 test , which promises to be faster and easy to perform without access to a full lab. Current coronavirus testing is based on PCR (polymerase chain reaction), the same technology used in DNA tests. This involves repeatedly heating the sample to amplify the genetic material so technicians can detect viral RNA. Sequencing those samples to hunt for viral genes requires expensive machines that many facilities don’t have, but the Sherlock method relies on a device similar to a pregnancy test. MIT’s Broad Institute developed Sherlock as a way to identify diseases with the clever addition of a reporter molecule with a DNA segment. Sherlock Biosciences now develops tests with this technology for specific diseases like COVID-19. CRISPR/Cas9 has gained fame as a powerful tool for genetic engineering, but that’s slightly different than the system devised by Sherlock. CRISPR is the sequence that guides Cas9 to the specific genetic code where you want to make a cut (known as cleaving), but scientists can also pair CRISP

All Related

Full Article

fda

Zydus Cadila gets USFDA nod to market generic drug

By www.financialexpress.com
Published On :: 2020-05-07T19:52:00+05:30

Deferasirox binds to iron and removes it from the bloodstream. It is used to treat iron overload caused by blood transfusions in adults and children who are at least two years old.

Full Article

fda

Dassault Systèmes and the FDA Extend Collaboration to Inform Cardiovascular Device Review Process and Accelerate Access to New Treatments

By www.3ds.com
Published On :: Tue, 16 Jul 2019 12:24:36 +0200

•An in silico clinical trial is underway with the 3DEXPERIENCE platform to evaluate the Living Heart simulated 3D heart for transforming how new devices can be tested •Five-year extension of their collaborative research agreement aims to spur medical device innovation by enabling innovative, new product designs •Both Dassault Systèmes and the FDA recognize the transformative impact of modeling and simulation on public health and patient safety

Full Article

fda

FDA: Unique Device Identification System

By www.healthcareinfosecurity.com
Published On ::

This proposed rule from the U.S. Food and Drug Administration would require unique identifiers on medical devices. While the rule aims to ease the collection and analysis of data about adverse health events and help detect counterfeit products, no patient information would be collected in a proposed new FDA database to help track the safety of these devices.

Full Article

fda

FDA approves Quidel's antigen test

By seekingalpha.com
Published On :: Sat, 09 May 2020 11:52:44 -0400

Full Article

QDEL

fda

FDA approves Israeli start-up Aidoc's AI to detect COVID-19 in CT scans

By www.jpost.com
Published On :: Sat, 09 May 2020 15:08:06 GMT

Aidoc's AI system can detect and prioritize findings from CT scans associated with coronavirus

Full Article

Artificial intelligence
start-up
Coronavirus
Coronavirus Live Updates

fda

Israel's Pluristem FDA approved for study in treatment of severe COVID-19

By www.jpost.com
Published On :: Fri, 08 May 2020 13:40:03 GMT

Six critically ill coronavirus patients in Israel who were considered high-risk for mortality were treated with Pluristem and survived.

Full Article

fda

Azərbaycan və Asiya İnkişaf Bankı (1999-2019): 20 illik tərəfdaşlıq

By feedproxy.google.com
Published On :: 2019-11-14 00:00:00

Bu nəşrdə Azərbaycanda şaxələndirilmiş, inklyuziv və dayanıqlı artım naminə Asiya İnkişaf Bankı (AİB) və Azərbaycan Hökuməti arasında əməkdaşlığın və birgə səylərin xülasəsi təqdim edilir.

Full Article

Publication

fda

FDA commissioner in self-quarantine after exposure to person with COVID-19

By feeds.reuters.com
Published On :: Sat, 09 May 2020 00:38:14 -0400

U.S. Food and Drug Administration Commissioner Stephen Hahn is in self-quarantine for a couple of weeks after coming into contact with someone who tested positive for COVID-19, an FDA spokesman told Reuters late on Friday.

Full Article

topNews

fda

FDA approves Eli Lilly drug for thyroid, lung cancers driven by a genetic mutation

By feeds.reuters.com
Published On :: Fri, 08 May 2020 17:58:16 -0400

The U.S. Food and Drug Administration on Friday approved a drug to treat lung and thyroid cancers driven by a specific genetic mutation that Eli Lilly and Co acquired with its 2019 purchase of Loxo Oncology.

Full Article

companyNews

fda

BRIEF-Eli Lilly Receives U.S. FDA Approval For Retevmo

By feeds.reuters.com
Published On :: Fri, 08 May 2020 21:40:25 -0400

* LILLY RECEIVES U.S. FDA APPROVAL FOR RETEVMO™ (SELPERCATINIB), THE FIRST THERAPY SPECIFICALLY FOR PATIENTS WITH ADVANCED RET-DRIVEN LUNG AND THYROID CANCERS

Full Article

companyNews

fda

U.S. FDA grants emergency use authorization to Quidel for first antigen test for COVID-19

By feeds.reuters.com
Published On :: Sat, 09 May 2020 10:53:54 -0400

The U.S. Food and Drug Administration (FDA) on Saturday approved emergency use authorization (EUA) to Quidel Corp for the first COVID-19 antigen test.

Full Article

companyNews

fda