November, 2020 Stories | FDA Reporter

By Press release submission | Nov 2, 2020

Cognita Labs issued the following announcement on Oct. 28.Cognita Labs, a leading respiratory technologies company, today announced that the U.S.

REGENERON PHARMACEUTICALS, INC.: FDA Accepts for Priority Review Libtayo® (cemiplimab-rwlc) for Advanced Non-small Cell Lung Cancer with PD-L1 Expression of ≥50%

By Press release submission | Nov 3, 2020

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo® (cemiplimab-rwlc) to treat patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression.

ONCOSEC: Announces FDA Clearance of IND Application for Initiation of Phase 1 Clinical Trial of its CORVax12 Vaccine Candidate for COVID-19

By Press release submission | Nov 3, 2020

First next-generation DNA vaccine candidate to deliver spike (S) protein from SARS-CoV-2 plus immune-stimulating interleukin-12 (IL-12) to elicit T-cell activation and drive robust humoral immunity

DIA: Granted FDA Clearance for its Cardiac Ultrasound AI Auto Views Selection

By Press release submission | Nov 4, 2020

This 7th FDA clearance further solidifies DiA's leadership in the ultrasound AI space.

ILLUMINOSS MEDICAL: Receives FDA Clearance for Use in Femur and Tibia Fractures as a Supplement to Approved Hardware

By Press release submission | Nov 4, 2020

IlluminOss Medical, a medical device company focused on minimally invasive orthopedic fracture repair, announced an expanded U.S. Food and Drug Administration (FDA 510k) clearance for its Photodynamic Bone Stabilization System.

RCPE: Awarded Two FDA Contracts for Next-Generation Pharma Technology

By Press release submission | Nov 5, 2020

The Research Center Pharmaceutical Engineering GmbH (RCPE), a global leader in pharmaceutical engineering sciences, has been awarded FDA funding for two projects commencing in the 4th quarter of 2020

SYNTELLIX AG: Breakthrough for Syntellix - MAGNEZIX implant has been granted designation as a "Breakthrough Device" by the U.S. FDA

By Press release submission | Nov 5, 2020

The U.S. Food & Drug Administration (FDA), Silver Spring / Maryland, has granted Syntellix's MAGNEZIX® CS 3.2 device and proposed indication for use the designation of a "Breakthrough Device".

SENHWA: Announces Multiple IND application submissions to U.S. FDA for Silmitasertib as a Potential Treatment for COVID-19

By Press release submission | Nov 6, 2020

Senhwa Biosicences, Inc. issued the following announcement on Nov. 2.Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company focused on next-generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, announced that it has submitted an Investigational New Drug (IND) application with the U.S.

BOSTON SCIENTIFIC: Receives FDA Approval for the Ranger™ Drug-Coated Balloon

By Press release submission | Nov 6, 2020

Company provides physicians with first portfolio comprised of drug-eluting stent and drug-coated balloon for the treatment of patients with peripheral artery disease

FDA: Permits Marketing of New Device Designed to Reduce Sleep Disturbance Related to Nightmares in Certain Adults

By Press release submission | Nov 9, 2020

The U.S. Food and Drug Administration permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD).

FDA: Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development

By Press release submission | Nov 9, 2020

Throughout my career as a cancer doctor and medical researcher, I have been concerned about and have sought to address issues related to health care disparities. One important step that researchers and medical product sponsors can take to confront health care disparities is to make sure that clinical trials for medical products are more inclusive of multiple populations.

CNS PHARMACEUTICALS: Announces Adaptive Trial Design For Berubicin Phase 2 Clinical Trial To Be Submitted for FDA Review

By Press release submission | Nov 9, 2020

CNS to Discuss Potentially Pivotal Phase 2 Trial for Berubicin in Webcast on November 12th; Adaptive Trial Design May Open Opportunity for Expedited Pathway for Development and/or Approval

IHRC, INC.: To help FDA advance laboratory safety and security

By Press release submission | Nov 10, 2020

On September 30, 2020, the U.S. Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (DHHS) awarded IHRC, Inc. a 5-year, indefinite delivery/indefinite quantity contract, with a ceiling value of $49.5 million to provide support to the Office of Laboratory Safety (OLS).

SALVIA BIOELECTRONICS: Receives FDA Breakthrough Device Designation for innovative neurostimulation solution

By Press release submission | Nov 10, 2020

Bioelectronics solution addresses drug-refractory chronic migraine

EMMAUS LIFE SCIENCES, INC.: FDA Approves Updated Label for Endari®

Emmaus Life Sciences, Inc. (OTC: EMMA), a leader in sickle cell disease treatment, announced revised prescribing information for Endari® to better inform healthcare professionals and sickle cell disease patients.

QUANSYS BIOSCIENCES: Receives FDA Emergency Use Authorization for its SARS-CoV-2 IgG Antibody Test that Provides Exceptional Clinical Performance

Quansys Biosciences announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its laboratory-based IgG antibody test.

SAFETY FIRST HEALTHCARE: CEO Shaun G. Morgan on the Extensive Offering of FDA-Certified Medical Products

Safety First Healthcare, a Delaware registered company registered with the Securities & Exchange Commission as a US-form 10 public company with factories in Vietnam specializing in the personal protective equipment business, offers an extensive range of personal protective equipment with FDA certifications for the medical community and the general public.

SENHWA BIOSCIENCES, INC.: CARE GA Receives Study May Proceed Letter from US FDA to Initiate Phase II Clinical Trial of Senhwa's Silmitasertib in COVID-19 Patients

Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company focused on next generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, announced its clinical partner- Center for Advanced Research and Education (CARE) in Gainesville, Georgia, has received a Study May Proceed letter from the US Food and Drug Administration (FDA) to begin a phase II investigator-initiated trial (IIT) evaluating Silmitasertib, a novel orally available casein

ACUPATH LABORATORIES, INC.: KDx Selects Acupath as Lab for URO17™ FDA Clinical Trial