On May 17, the U.S. FDA authorized a booster of Pfizer’s vaccine for kids ages 5 to 11 years. The action comes as major cities are announcing a rise in cases. Additionally, COVID-19 would have claimed over 110,000 more lives in 2021 if not for the Pfizer-BioNTech vaccine, according to a Pfizer-sponsored report on the first year of the U.S. vaccination program.
Almost three times as many people have died as a result of COVID-19 as official data show, according to a new World Health Organization (WHO) report, the most comprehensive look at the true global toll of the pandemic so far.
Deaths associated with Astellas Pharma’s gene therapy program for patients with X-linked Myotubular Myopathy underscore some of the risks of developing potential one-and-done treatment options for serious diseases.
Two months after receiving a gene-edited pig heart, David Bennett Sr. passed away at the age of 57 years.
The U.S. Food and Drug Administration placed a partial clinical hold on Alpine Immune Sciences’ NEON-2 trial, which is evaluating davoceticept (ALPN-202) in combination with Merck’s immunotherapy pembrolizumab (Keytruda) in adults with cancer.
According to the U.S. Food and Drug Administration’s Adverse Events Reporting System (FAERS), three more deaths have been reported potentially associated with the Alzheimer’s drug Aduhelm since Biogen indicated during November 2021 that the company was investigating the death of a 75-year-old woman who died from a brain abnormality.
The U.S. Food and Drug Administrationlifted a clinical hold on Audentes Therapeutics’ ASPIRO trial studying AT132 as a potential treatment for X-linked myotubular myopathy (XLMTM), a rare neuromuscular disease.
The U.S. Food and Drug Administration placed a clinical hold on patient enrollment and dosing in an early-stage trial of the Bellicum Pharmaceuticals’ cancer treatment BPX-601, after the death of a patient.
South San Francisco-based Allogene Therapeutics released some early data from the company’s UNIVERSAL clinical trial of ALLO-715 for relapsed/refractory multiple myeloma.
Brazilian health authority Anvisa said a volunteer in a clinical trial of the Covid-19 vaccine developed by AstraZeneca and Oxford University died, stating it had received data from an investigation into the matter.
