MIAMI, May 05, 2020 — Organicell Regenerative Medicine, Inc. (OTCBB:BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, announced today that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for its lead product, Organicell Flow, for patients diagnosed with moderate to severe acute respiratory syndrome (SARS) due to COVID-19 infection. [Read more…]
BioStem Technologies Announces Corporate Update on Company Direction
Pompano Beach, FL, April 29th, 2020 — BioStem Technologies, Inc. (OTC PINK: BSEM) (“BioStem” or the “Company”) a leading life sciences company specializing in perinatal tissue-based allografts for use in regenerative therapies, today announced a corporate update on the Company’s direction.
The Company announced that it embarked on a new initiative to define its two distinct business pillars, BioStem Technologies and BioStem Life Sciences. The new strategic focus of BioStem Technologies is to identify, develop and market the life changing regenerative biologics, formally spearheaded by BioStem Life Sciences. This includes an all new biologic therapeutic pipeline focused on Acute Respiratory Distress Syndrome (ARDS) and Osteoarthritis (OA). BioStem Technologies will also assume the sales and distribution of the RHEO™, VENDAJE™, VENDAJE™ AC, and VENDAJE™ OPTIC brands. [Read more…]
Caladrius Biosciences to Assess Cell Therapy (CLBS119) for COVID-19 Induced Lung Damage
FDA authorizes new IND for the study of CLBS119 in COVID-19 patients who experienced respiratory failure
BASKING RIDGE, N.J. (April 23, 2020) – Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the “Company”), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse, not manage, disease today announced that the U.S. Food and Drug Administration (“FDA”) has authorized its investigational new drug (“IND”) application for the study of CLBS119, a CD34+ cell therapy for repair of COVID-19 induced lung damage. The study will target patients with severe SARS-CoV-2 infection that required ventilatory support due to respiratory failure. [Read more…]
Novartis’ Kymriah® Wins Latest FDA RMAT (42 Announced)
Novartis Kymriah® receives FDA Regenerative Medicine Advanced Therapy designation in follicular lymphoma.
- If approved, relapsed or refractory (r/r) follicular lymphoma would become the third B-cell malignancy indication for Kymriah, joining approvals in children and young adults with r/r ALL, and adults with r/r DLBCL
- The Regenerative Medicine Advanced Therapy (RMAT) designation reflects the unmet need for patients with r/r follicular lymphoma
- US regulatory filing for Kymriah in r/r follicular lymphoma anticipated in 2021
Capricor Treats Two COVID-19 Patients with Cardiosphere-Derived Cells (CAP-1002)
Capricor Initiates Compassionate Use Program for Severe COVID-19 Patients using CAP-1002, its Novel Cell Therapy.
LOS ANGELES, April 03, 2020 — Capricor Therapeutics (NASDAQ: CAPR) a clinical-stage biotechnology company focused on the development of first-in-class biological therapeutics for the treatment or prevention of serious diseases, announced it is providing CAP-1002, its novel cell therapy to patients with advanced COVID-19 under the compassionate use pathway. [Read more…]
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