by John Conrad | Jun 27, 2024 | Policy News
In a significant move to address longstanding issues of underrepresentation in medical research, the U.S. Food and Drug Administration (FDA) has released a draft guidance document aimed at increasing diversity in clinical trials. This much-anticipated guidance, titled...
by John Conrad | Jun 27, 2024 | NewsBrief
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Epkinly (epcoritamab-bysp), a joint development by AbbVie and Genmab, for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL). This approval specifically...
by John Conrad | Jun 10, 2024 | NewsBrief
In a significant development for patients with vanishing white matter (VWM) disease, AbbVie and Alphabet’s Calico announced on Friday that their investigational eIF2B activator, fosigotifator, has been selected to participate in the FDA’s new Support for...
by John Conrad | May 29, 2024 | Policy News
The FDA issued draft guidance outlining a new “platform designation” that companies can apply for as part of a broader initiative to modernize the agency’s approach to medicines developed using cutting-edge genetic technologies. This guidance proves...
by John Conrad | Mar 26, 2020 | COVIDFDA
The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from threats including emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to...
