FDA grants approval to two of three indications for gram-negative antibiotic based on Phase II data, but follows it advisors in rejecting a third indication that came without human data, offering hints of what the limitations and possibilities of a formal limited population antibiotic approval pathway might be.
Allergan PLC/AstraZeneca PLC received a limited use indication for the gram-negative antibiotic Avycaz (ceftazidime/avibactam), setting up a test-run for how FDA may handle a formal limited-population drug approval pathway.
The combination antibiotic was cleared Feb. 25 based on Phase II data, for use in adults with complicated intra-abdominal infections...
FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user free appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.
The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.
An unintended consequence of a provision framed as an administrative change in the bill could significantly reduce medication adherence among low-income older adults and increase mortality, a study found.
The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.
HHS Secretary Kennedy's new ACIP appointments include multiple members of anti-vaccine groups and people who have spread misinformation about COVID-19 vaccines.
Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.
The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.
