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Latest From Michael Cipriano
Pink Sheet reporters discuss the proposed opioid lawsuit settlement, Public Citizen's opioid citizen petition denial, and the upcoming FDA public meeting on opioid standards, as well as a proposal to better outline agency flexibility with rare disease drugs.
Many stakeholders interviewed by the GAO find the US FDA's updated guidance on treatment of adverse event data gathered under expanded access to be helpful, but some continue to be concerned that the data will be used to negatively impact development programs.
Boehringer Avoids Further Efficacy Study Of Ofev In SSc-ILD With Full Approval, No Post-Marketing Commitments
Despite concerns from members of US FDA's Arthritis Advisory Committee that the efficacy profile of Boehringer Ingelheim's Ofev needs more study in the SSc-ILD indication, the company does not have any such postmarketing requirements or commitments.
Keeping Track: Ofev Snags SSc-ILD Indication, Accelerated Approval Reviews For Veverimer And Voxelotor, J&J Gets Its First Vaccine BTD
The latest drug development news and highlights from our US FDA Performance Tracker.
Pink Sheet Podcast: Sharpless' Future, Sharpless On Data Manipulation, and Mylan's Insulin Complete Response Letter
Pink Sheet reporters discuss the questions about Acting Commissioner Norman Sharpless' future at the US FDA, his comments about the data manipulation scandal, and the complete response letter that is delaying Mylan's follow-on insulin product.