Clinical research
Gilead has announced they are pulling cancer drug Zydelig (idelalisib) off the market for certain types of cancer after failing to complete follow-up clinical trials to confirm efficacy and safety.
The San Diego-based immunology company is locating and developing molecules where the mechanism of action has either been proven or makes sense.
January has been a largely quiet month for PDUFA dates on the U.S. Food and Drug Administration (FDA)’s calendar. There were two dates for the entire month, and one of those has been moved back to April. Here’s a look.
Pazdur, along with the FDA’s R. Angelo de Claro and Gautam Mehta from the Center for Drug Evaluation and Research, penned an opinion piece published Thursday in JAMA Oncology.
The Glycogen Storage Disease Program at Connecticut Children’s and UConn Health reported success in a Phase I/II trial of a gene therapy for GSD-Ia.
The data is coming in right away for Alnylam in one of its primary indications, transthyretin-mediated (ATTR) amyloidosis.
The FDA has lifted the partial hold on Kura Oncology’s KOMET-001 Phase IB trial on a potential treatment for acute myeloid leukemia.
As part of a company-wide workforce reduction, it will cut its employee headcount by at least 25% by the end of the year, and 50% of its senior management team are leaving the company.
Dr. Anthony Fauci expects the FDA will authorize the Pfizer-BioNTech vaccine for children under the age of five in the next month.
ImmPACT Bio provided an optimistic update on a Phase I clinical study evaluating its CD19-CD20 bi-specific Chimeric Antigen Receptor T-cell (CAR-T) therapy.
PRESS RELEASES
