J&J’s Doribax Is Subject Of FDA’s First "Complete Response" To An NDA
FDA is seeking additional information on Johnson & Johnson's Doribax (doripenem) prior to approving the antibiotic for the treatment of hospital-acquired pneumonia, including ventilator-associated pneumonia, the company announced Aug. 21
More from Archive
More from Pink Sheet
The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.
The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.
MFN policy would would apply to all single source drugs in all insurance markets, according to HHS release. Secretary Robert F. Kennedy Jr. said the department is discussing the plan with drug sponsors.