Food and Drug Administration (FDA)
NEWS
The latest warning letter asks Medtronic to update its systems and procedures in order to deliver safe and high-quality devices to consumers.
The FDA’s approval of Xeljanz is based on Pfizer’s Phase III multicenter, double-blind, placebo-controlled study. Here are more details about the study.
Texas’ top law enforcement official is taking aim at two drug companies over what he alleges is the promotion of hormone blockers for children experiencing gender dysphoria.
The FDA said that it is not authorizing molnupiravir’s use during pregnancy as there are hardly any clinical scenarios where the benefits appear to outweigh the risks.
The lawsuit was filed by Public Health and Medical Professionals for Transparency, a nonprofit organization recently formed with a mission to obtain the data for the COVID-19 vaccines.
Cidara Therapeutics and Mundipharma today shared positive topline results from their Phase III trial on the use of rezafungin for candidemia and invasive candidiasis.
As of now, six studies related to islatravir are on full clinical hold, while seven are on partial clinical hold. Here are more updates on the development of this drug.
Takeda will present nine abstracts at the annual ASH meeting, including data for its hemophilia program, as well as announcing a new sickle cell disease program.
At the ASH meeting, Bristol Myers Squibb and Kite Pharma presented promising data from CAR-T programs aimed at relapsed or refractory large B-cell lymphoma.
JOBS
IN THE PRESS