$AXSM the principal reasons given in the CRL relate to CMC considerations.
The CRL identified the need for additional CMC data pertaining to the drug product and manufacturing process.
BrightFarms is recalling packaged salad greens produced in its Rochelle, IL greenhouse farm because it has the potential to be contaminated with Salmonella. Consumers, restaurants, and retailers should not eat, sell or serve the affected products: https://t.co/RnVZC1ffgu
@DrWoodcockFDA@FDAMedia@WHO Please allow $NVAX to file EUA now. People hesitate to get mRNA vaccines bc of side effects w 2nd dose. If FDA is struggling with issuing an EUA prior to the completion of a US study, then the current data should be sufficient - not ethical to continue a placebo controlled study
A 'must-see' enjoyable session by @statnews@matthewherper w/ four former FDA Commissioners @ScottGottliebMD, @califf001, Hamburg & Henney with informal engaging banter & insights you never get while they are with the Agency! Also strong statement of support for @DrWoodcockFDA!
"There are challenges, but it's up to you to grasp them and turn them into opportunities." Hear from Vineet S. about what makes SRPT unique: https://t.co/8ggT0lZ8f4
@US_FDA’s Peter Marks reiterates the agency’s continued commitment to #genetherapy in a call today with the Alliance for Regenerative Medicine’s Executive Committee. Marks says there have been no changes to FDA’s policies or approaches to gene therapies.
Our long-serving CFO, Sandy Mahatme, is retiring from Sarepta this month. He’s had a big impact on our transformation and his outsized personality will be missed. Today we celebrate his accomplishments and extend our gratitude.
Our SVP of Global Policy, Government and Patient Affairs, Diane Berry, was recently interviewed on the @patientsrising podcast, discussing the 21st Century Cures Act.
5/ Now everyone in the world is fighting for their lives with little hope, no cure, and no guarantee of survival—all while suffering financial hardship. Reassurance is now doctors saying there’s nothing they can do.
Now the world knows what it’s like to be rare disease patient.