Federal Register notice: FDA withdraws three NDAs from multiple applicants after they notified the agency that the products were no longer marketed....
FDA approves Amgens Bkemv as an interchangeable biosimilar for Alexions Soliris, indicated to treat two rare diseases.
Johnson & Johnson reports positive topline results from its pivotal Phase 3 MDD3001 clinical trial evaluating the efficacy and safety of seltorexant a...
The American Clinical Laboratory Association and HealthTrackRX sue FDA to block the agencys final rule asserting authority over laboratory-developed t...
FDA grants Eli Lilly accelerated approval for Retevmo (selpercatinib) for pediatric patients two years of age and older with advanced or metastatic me...
CDER posts a list of 10 things it says people should know about the Centers pharmaceutical quality function.
Medline Industries recalls (Class 1) its Medline Sub-G Endotracheal Tube with Subglottic Suctioning after complaints were received about the devices i...
A bipartisan group of 11 Senate and House members asks FDA to require hearing aid labeling to disclose if the device uses proprietary software that af...
