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The question before the committee was whether the benefits of teplizumab outweigh the risks as it voted 10-7 in favor of the drug to delay clinical type 1 diabetes mellitus.
The FDA has a massive backlog of site inspections due to the pandemic. To address the problem, the agency made its Resiliency Roadmap outlining its priorities.
To develop and commercialize them with maximum efficiency, the FDA, scientists and developers must innovate, according to panelists speaking during the Presidential Plenary on Commercialization at the International Society of Cell & Gene Therapy on May 26.
Fennec is looking for a second chance to approve PEDMARK, its pediatric chemotherapy-induced hearing loss prevention drug, as it resubmits its NDA for the agent to the U.S. FDA.
Bristol Myers Squibb has been busy the last two weeks with a string of approvals, positive clinical trial updates and deals. Here’s a look.
Loncastuximab tesirine-lpyl just got accelerated approval from the U.S. Food and Drug Administration (FDA). This is a systemic therapy for people with diffuse large B-cell lymphoma (DLBCL).
Biopharma and life sciences companies strengthen their leadership teams and boards with these Movers & Shakers.
A two-stage Phase III clinical trial by Sanofi and GSK, is studying a COVID-19 vaccine candidate targeting the original SARS-CoV-2 strain as well as the South African B.1.351 variant.
Controlling interruptions when working from home can be challenging, but a little planning and some established rules can help.
The funds will enable Esco that provides life sciences tools and services, to expand its toehold in China and the United States.
Are you an introvert who is worried about your performance? Well, do you know that these unique skills can make you an excellent leader? Let’s find out those skills.
Determined to take its next-generation engineered cell therapies to the next level, BlueRock teams up with Senti Biosciences with futuristic medicines in mind.