U.S. FDA Lists Applied DNA’s Linea™ COVID-19 Assay Kit as 1 of Only 2 EUA-Authorized Tests Able to Detect S-Gene Mutation Found in SARS-CoV-2 U.K. Variant (B.1.1.7)
(FDA) published a safety communication (the "Communication") that identifies the Company’s Linea™ COVID-19 Assay Kit (the "Assay Kit") as one of only two tests marketed under the FDA’s Emergency Use...
DBV Technologies Spikes on Positive FDA Communication
DBV Technologies received positive responses from the U.S. Food and Drug Administration regarding its application for a peanut allergy treatment.
The U.S. FDA provided type A meeting requests to the questions the French company submitted in October following its receipt of a complete response letter in...
Avinger Initiates Full Commercial Launch of Tigereye(TM) Image-Guided CTO Crossing Catheter
With the initiation of full commercial launch, current and prospective accounts throughout the US and Germany are now able to order the Tigereye device.
During the fourth quarter of 2020, Avinger conducted a limited launch at 12 clinical centers in the U.S. and Germany....
Quanterix Receives FDA Emergency Use Authorization for SARS-CoV-2 N Protein Antigen Test
As case counts and positivity rates rise globally, the COVID-19 testing landscape is of critical importance
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Acorda Therapeutics Announces Agreement for Sale of Manufacturing Operations and Long-Term Global Supply Agreement for INBRIJA®, Corporate Restructuring, and Enters into "At The Market" Offering Agreement
$80 million up-front payment will substantially increase cash balance
Sale, restructuring and other operating expense reductions will reduce annual operating...
Biomerica’s Fast 15-Minute Simple to Use Covid-19 Antigen Rapid Test Receives CE Mark
Biomerica receives first orders and plans to ship tests in coming weeks
Clinical studies demonstrated an overall performance of 94.7% positive agreement (sensitivity) and 99.7% negative agreement (specificity) as compared to lab-based molecular PCR tests
The Company has...
BIOLASE Announces Agreement With DSO Dental Care Alliance To Expand Laser Adoption In Dental Offices Across The United States
BIOL announced an agreement with Dental Care Alliance (DCA), one of the largest dental support organizations (DSO) in the United States with more than 330 affiliated practices in 20 states, to expand laser adoption and hands-on training...
This NCNA Penny Stock Could Surge Over 300%, Say Analyst
NuCana uses a phosphoramidate chemistry technology called ProTide to create a class of drugs that will surmount the limitations of the existing nucleotide analogs behind many chemotherapy drugs. NuCana’s ProTides have already been used in Gilead’s antiviral drug Sovaldi.
In May of last year, NuCana...
This ACRX Penny Stock Could Surge Over 300%, Say Analysts
AcelRx is a pharmaceutical company dedicated to the creation of safer treatments for acute pain, developing synthetic opioid drugs for sublingual (under the tongue) dosing.
The company’s main product, Sufentanil, was approved by the FDA under the name Dsuvia in 2018, and by the EU as Dzuveo that same...
T2 Biosystems T2SARS-CoV-2™ Panel Proves Effective Amid Global Rise in Variants of the SARS-CoV-2 Virus
Panel can detect multiple variants of the SARS-CoV-2 virus, including those most recently identified in the United Kingdom, South Africa, and the U.S.
T2SARS-CoV-2 Panel, which has demonstrated clinical sensitivity of 95 percent and specificity of 100...
La Jolla Pharmaceutical Company Announces Exclusive Licensing Agreement for GIAPREZA™ (Angiotensin II) and XERAVA™ (Eravacycline) in Europe
La Jolla to receive upfront cash payment of $22.5 million plus potential commercial milestone payments of up to $109.5 million and double-digit tiered royalty payments
Under the terms of the exclusive licensing agreement, La...
Day Traders Lighting Up Reddit Spur Rally in Tiny Health Stock Zomedica
Such outsized moves in small-caps are becoming par for the course these days.
Surging at the open on the back of mentions in Reddit forums was Zomedica Corp., a company that develops medicines for pets. The stock jumped as much as 98% on Monday and is up almost four-fold from the start or...
Day Traders Lighting Up Reddit Spur Rally in Tiny Health Stock TRXC
The stock has surged about 180% since the start of the new year. Today’s trading volume was more than 13 times normal. The penny stock garnered a mention in several Reddit forums over the past few days, with one user comparing it with the roughly $95 billion market-cap leader in surgical...
GeoVax Awarded NIH Grant to Advance COVID-19 Vaccine Development
announced today that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has awarded the Company a Small Business Innovative Research (SBIR) grant in support of its development of a vaccine against SARS-CoV-2, the virus that causes...
Single Dose of Rexlemestrocel-L Provides Substantial and Durable Reduction in Heart Attacks, Strokes and Cardiac Death in Patients With Chronic Heart Failure
results from the landmark DREAM-HF randomized controlled Phase 3 trial in 537 treated patients with chronic heart failure with reduced left ventricular ejection fraction (HFrEF) who received rexlemestrocel-L...
C4 Imaging Announces Sirius Positive Signal MRI Marker Given FDA 510(k) Clearance for Use with Isoray’s Cesium-131 Brachytherapy Seeds to Treat Prostate Cancer
ISR has received FDA 510(k) clearance for the use of C4 Imaging’s Sirius® positive-signal MRI (Magnetic Resonance Imaging) Markers with Isoray’s Cesium-131, brachytherapy seeds.
Sirius MRI Markers will...
is engaged in the development of gene therapies for rare, frequently terminal, diseases, including neurometabolic disorders, primary immune deficiencies, and blood disorders. The gene therapy approach uses blood stem cells to deliver corrected genetic information directly into the patient’s body.
Orchard’s pipeline demonstrates the diversity of disorders amenable...
“Strong Buy” Penny Stock That Could Deliver Massive Returns
The company’s development pipeline features drug candidates under investigation as treatments for short bowel syndrome (SBS) and celiac disease (CeD), two conditions that are both dangerous and difficult to treat.
9 Meters’ flagship product, Larazotide, is in Phase 3 development for the treatment of...
