After complete response letter, Lexicon triggers rarely used mechanism for formal hearing, prompting US FDA to publicly list its problems with the proposed type 1 diabetes drug, for which Sanofi had originally sought approval.
Lexicon Pharmaceuticals, Inc. expects to request a formal hearing to overturn the US Food and Drug Administration’s rejection of sotagliflozin in type 1 diabetes, and clarify the product’s prospects in the disease.
The company is able to request a hearing with the FDA commissioner after a series of complete response letter appeals were denied. FDA officials offered a detailed glimpse into the...
The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.
Pink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters.
The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.
The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.
The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.
Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.
FDA Commissioner Martin Makary will give industry a new avenue for access and influence despite his and HHS Secretary Robert F. Kennedy Jr.’s claims that the pharma-FDA relationship is too cozy.
