[ Price : $8.95]
Zymeworks reports that its HER2-targeted bispecific antibody Ziihera (zanidatamab-hrii) significantly improved outcomes for patien...[ Price : $8.95]
FDA posts a Form 483 that cites significant lapses in aseptic manufacturing practices at Sanofis sterile drug-product facility in ...[ Price : $8.95]
FDA posts a final guidance entitled Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Pare...[ Price : $8.95]
Bristol Myers Squibb (BMS) and Johnson & Johnson stop their Phase 3 Librexia ACS trial of the investigational anticoagulant milvex...[ Price : $8.95]
FDA commissioner Marty Makary and CBER director Vinay Prasad preview upcoming agency reforms during an FDA Direct podcast focused ...[ Price : $8.95]
An Axios report examines growing criticism of recent FDA actions that are fueling uncertainty among drug developers and weakening ...[ Price : $8.95]
The ACLU files a lawsuit seeking to force FDA to release documents related to its ongoing safety review of mifepristone.[ Price : $8.95]
FDA says it is approving new labeling submitted by Sarepta Therapeutics for its gene therapy Elevidys (delandistrogene moxeparvove...