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).
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
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.
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).
Company provides physicians with first portfolio comprised of drug-eluting stent and drug-coated balloon for the treatment of patients with peripheral artery disease
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.
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".
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
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.
This 7th FDA clearance further solidifies DiA's leadership in the ultrasound AI space.
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
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.
Cognita Labs issued the following announcement on Oct. 28.Cognita Labs, a leading respiratory technologies company, today announced that the U.S.
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas" ) announced today that the United States ("U.S.") Food and Drug Administration (FDA) has granted Fast Track designation based on nonclinical and clinical data for the development of ASP5354, an imaging agent being investigated for intraoperative ureter visualization in patients undergoing minimally invasive and open abdominopelvic surgeries.
First FDA-cleared thermoset bioresorbable synthetic polymer
The First Ever Solution to Enable Digitization and Analysis of Full Field Peripheral Blood Smears with Decision Support System (DSS) Tailored to Augment Hematology Diagnostics
Dr. David Berger of Wholistic Pediatrics & Family Care comments on FDA's actions concerning public input on COVID-19 vaccine
Cannabics Pharmaceuticals Inc. recently issued the following announcement.Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a global leader in the development of cancer related cannabinoid-based therapeutic formulations and medicines, announced today that it has signed an agreement with a leading clinical quality and validation processes consultancy to oversee the preparation and submission of a Pre-IND Meeting request to the FDA on its anti-tumor Drug Candidate CANNABICS™ RCC-33, the world's first cannabinoid-based antitumor Drug Candidate for the treatment of Colorectal Cancer.
This is the company's 6th FDA clearance and further solidifies its leadership as the most comprehensive acute AI vendor in the market
Comprehensive portfolio is the first of several planned plating releases for the distal extremities