Pfizer wants advisory committee to endorse several labeling changes for its smoking cessation drug, but FDA says decision should wait for post-marketing trial set to be completed in about a year.
Pfizer Inc. may have to convince an advisory committee and FDA officials not to wait another year for a post-marketing trial to be completed before considering taking a boxed warning for severe neuropsychiatric events out of the Chantix label.
Data from a meta-analysis of several trials as well as observational studies that the company submitted in a labeling supplement...
A Johnson & Johnson executive tells the Pink Sheet in an interview how the company developed its pretzel-shaped intravesical drug releasing system for gemcitabine, which used design and materials to improve efficacy and ease bladder cancer treatment.
The former CDC director and recently departed chief medical officer tell senators that Kennedy plans to target the childhood vaccine schedule despite a lack of scientific data to support his agenda.
The FDA said new molecular entity application reviews increased and cost less in fiscal year 2024, a potentially encouraging sign for industry.
The Give Kids A Chance Act would renew the PRV program that began to sunset in December 2024. The House Energy and Commerce Committee advanced the pediatric- and rare disease-focused package, but also included generic drug transparency provisions.
The Give Kids A Chance Act would renew the PRV program that began to sunset in December 2024. The House Energy and Commerce Committee advanced the pediatric- and rare disease-focused package, but also included generic drug transparency provisions.
Recently released CRLs for unapproved products contain recommendations for new studies, including design element details and advice to consider different submission pathways.
The US FDA may ask sponsors for permission to train AI models using data from new drug applications. Alternatives to animal testing could be a test case.
