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ONCOPEPTIDES: Has submitted an Investigational New Drug application to FDA for the second drug candidate from the PDC platform

Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) today announces that the Company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), for OPD5 - a second drug candidate based on the proprietary Peptide Drug Conjugate platform (PDC).

FRESENIUS MEDICAL CARE: FDA Approves New Container System for Peritoneal Dialysis Solutions

Fresenius Medical Care North America Announces Next Generation Solution Bags to Support Continued Home Dialysis Expansion

EZRA: Receives FDA Clearance for Prostate Cancer Artificial Intelligence

Ezra's Prostate AI is the first to ever be cleared by the FDA for prostate and lesion segmentation using AI

ASTELLAS PHARMA INC.: U.S. FDA Grants Fast Track Designation for ASP0367/MA-0211, a Selective PPARδ Modulator being Developed for the Treatment of Primary Mitochondrial Myopathies

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas" ) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of ASP0367/MA-0211 ("ASP0367") as a potential treatment for primary mitochondrial myopathies (PMM).

TYBER MEDICAL: Receives FDA Clearance on Foot and Ankle Plating Systems

Comprehensive portfolio is the first of several planned plating releases for the distal extremities

AIDOC: Granted AI industry-first FDA clearance for triage of incidental pulmonary embolism

This is the company's 6th FDA clearance and further solidifies its leadership as the most comprehensive acute AI vendor in the market

CANNABICS PHARMACEUTICALS: Prepares to Submit the FDA with a pre-IND Meeting Request for its Proprietary Colon Cancer Drug Candidate, CANNABICS™ RCC-33

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.

WHOLISTIC PEDIATRICS & FAMILY CARE: FDA Vaccine Approval Committee Fails to Solicit Public Input Despite Widespread Concerns

Dr. David Berger of Wholistic Pediatrics & Family Care comments on FDA's actions concerning public input on COVID-19 vaccine

SCOPIO LABS: Receives FDA Clearance for its AI-Powered Full Field Peripheral Blood Smear (Full Field PBS) Application

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

FDA Reporter