Keeping Track: Submissions Complete For Breakthrough Therapies From Portola And Catalyst; FDA Finally Approves Bridion, Basaglar
The latest drug development news and highlights from our FDA Performance Tracker.
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If approved, Zolyd will be the first intravenous epoxide antibiotic approved in the US, with greater potency than the oral version used first-line. Ex-US, the I.V. formulation has demonstrated a stable resistance profile.
Phase III protocols for COVID-19 vaccine candidates from Pfizer/BioNTech, Moderna, AstraZeneca and Johnson & Johnson are similar – but definitely not the same.
In remarks fleshing out the ‘EUA Plus’ guidance before it became a political football, Operation Warp Speed’s Slaoui said that an FDA analysis concluded that 90% of adverse events related to vaccination take place within the first 42 days.