Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
You may also be interested in...
Modeling Is Not a Drug Approval Pathway: Why Merck Flunked Keytruda’s TNBC Advisory Panel
Advisory panel agrees with US FDA that Merck’s pathological complete response data is not strong enough for accelerated approval in high-risk, early-stage triple-negative breast cancer patients and says modeling of expected outcomes data cannot make up for this weakness.
We Still Can’t Hear You: 11 Months Into Pandemic, Virtual US FDA Meetings Still Challenging
With J&J’s panel upcoming, it’s worth reflecting on last year’s COVID-19 vaccine advisory committee meetings. Moderna’s went a bit smoother than Pfizer’s, but hiccups still raise questions about whether agency is getting the advice it needs.
ASCO 2023 – Bicara Eyes Head And Neck Niche
Impressive data in HPV-negative disease, potentially beating Keytruda, has the private group making pivotal plans.