Novavax says its Covid-19 vaccine BLA is being held up while FDA seeks to conclude a post-marketing commitment from the company.
FDA grants CereVasc a breakthrough device designation for its investigational eShunt System and its use in treating communicating hydrocephalus.
FDA says its Electronic Submission Gateway Next Generation is live and ready to receive submissions.
Vanda Pharmaceuticals criticizes FDA for wrongly claiming that recent staff cuts and a new commissioner causes it to delay a company request for a hea...
Akeso says its ivonescimab met the primary endpoint in a pivotal Phase 3 trial for the first-line treatment of advanced squamous non-small cell lung c...
The Association for Clinical Oncology tells the new leaders of FDA, NIH, and CMS it looks forward to working with them on behalf of cancer research an...
Bristol Myers Squib says its Cobenfy showed positive results in the Phase 3 ARISE trial as an adjunctive therapy to atypical antipsychotics for patien...
Former FDA associate commissioner Peter Pitts calls on the agency to revise drug labels with obesity safety and effectiveness information.
