Germany’s Bayer won fast-track status from U.S. drugs regulators for a new blood thinner designed to prevent certain types of strokes, as the company seeks to follow up on the success of the anticoagulant Xarelto.
Germany’s BioNTech on November 19 was awarded fast track designation by the U.S. Food and Drug Administration for the speedy review of a novel skin cancer therapy, which is based on RNA technology similar to the one that underpins the company’s Covid-19 vaccine.
Bluebird bio placed the company’s Phase I/II and Phase III trials of LentiGlobin gene therapy for sickle cell disease (SCD) on temporary suspension.
The U.S. Food and Drug Administration granted various designations for Sanofi’s avalglucosidase alfa for Pompe disease, Sanofi’s rilzabrutinib for immune thrombocytopenia, and ViiV Healthcare’s cabotegravir for HIV prevention.
Novavax Inc. is on track to begin a delayed U.S.-based, late-stage study of the company’s experimental coronavirus vaccine during November
Critically ill Covid-19 patients recovered rapidly from respiratory failure after three days of treatment with RLF-100, a therapy granted fast-track designation in the United States, two drug companies said on Sunday.
Atox Bio had positive results in the company’s Phase III ACCUTE trial for reltecimod for early treatment of severe Necrotizing Soft Tissue Infection (NSTI), a so-called flesh-eating disease.
MetVital’s lead drug candidate “Anhydrous Enol-Oxaloacetate” (AEO) received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of patients with newly diagnosed glioblastoma multiforme.
The software of life is how Moderna Inc. CEO Stephane Bancel describes messenger RNA (mRNA), which is at the core of the company’s drug development process.
Purdue Pharma filed for Chapter 11 bankruptcy and agreed to pay between $10 and $12 billion to settle the drug manufacturer’s involvement in the health-care crisis.