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Latest From Michael Cipriano
The latest drug development news and highlights from our US FDA Performance Tracker.
Pink Sheet Podcast: Zolgensma Saga Continues, ICER Reviews DMD Drugs, FDA Issues Another LPAD Approval
Pink Sheet reporters review Novartis' latest response to Zolgensma data manipulation, discuss ICER reviews of Sarepta's Duchenne muscular dystrophy treatments, and recap the FDA's latest antibiotic approval.
US FDA's approval of the TB Alliance's pretomanid regimen for highly treatment-resistant tuberculosis comes with an LPAD designation and advisory committee-requested language to limit use.
Roche's Richard Peck says adoption of outcomes-based pricing in the US could be powerful incentive to study precision dosing, although he also calls on drugmakers to put out scientific examples.
CDER's Robert Temple said the US FDA has generally been nervous about using PK/PD analyses to support labeling changes, but that it might be time to rethink the subject.