Regulatory
On Tuesday, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 21-0 with one abstention to recommend authorization of Novavax’s COVID-19 vaccine.
For the first time in half a decade, the FDA will convene to address two therapies developed by bluebird bio that could have ripple effects across the industry regarding lentiviral vectors.
Data presented in bladder and pancreatic cancer at ASCO underscore the company’s vision of using NK cells and T cells to target difficult-to-treat cancers.
The WHO reports it’s too early to tell if the monkeypox outbreak could become a pandemic, but believe there is a window of opportunity to control the cases.
The FDA has decided to extend the Prescription Drug User Fee Act (PDUFA) review date for TG Therapeutics’s ublituximab until December 2022.
On June 5, the FDA is expected to decide the fate of Acer Therapeutics’ experimental treatment for Urea Cycle Disorders (UCDs), ACER-001. CEO Chris Schelling spoke with BioSpace.
Antios Therapeutics received a clinical hold on its Hepatitis B virus (HBV) combinatorial therapy from the U.S. Food and Drug Administration on Wednesday.
Vanda has again taken legal action against the FDA over its supposed failure to grant tradipant Fast Track designation. In its complaint, Vanda is challenging the FDA’s decision to deny the designation.
If approved, etranacogene dezaparvovec would be the first gene therapy treatment for hemophilia B.
The American Society of Clinical Oncology and the Association of Community Cancer Centers are combining their efforts to increase racial and ethnic diversity in clinical trials.
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