BioMarin Official Calls Drisapersen AdCom ‘Critical Thinking On Display’
CMO says advisory committee was tough on proposed Duchenne muscular dystrophy treatment in part because it was first to reach that stage.
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Advocates counter FDA’s problems with Duchenne muscular dystrophy treatment's trial data using real-life experience.
OCE Director Richard Pazdur was less sanguine, however, noting that while the Pepaxto withdrawal may have been faster than others, it still required more than 60 meetings to complete.
Singulair’s Psychiatric AE Risks Still A Problem, But US FDA Has Limited Mitigation Options Remaining
Stakeholders suggested a ‘Dear Healthcare Provider’ letter or speaking about the risks to professional societies to emphasize the psychiatric adverse events that prompted a boxed warning for the now-generic asthma drug montelukast. The NY Attorney General is adding more pressure.