Although not bound to the committee’s recommendations, the FDA does take them into consideration when making decisions on approval. A regulatory decision is expected on December 20, 2024. If approved, ...
Shares of Lexicon Pharmaceuticals tanked nearly 33.6% as of 11:30 am ET after the drug company’s sotagliflozin drug candidate received a negative vote by a US Food and Drug Administration (FDA) panel, ...
Committee members said there was uncertainty around sotagliflozin in patients with kidney disease. The FDA is currently reviewing the oral therapy as an adjunct to insulin to help control glycemic ...
Lexicon Pharmaceuticals shares tumbled in premarket trading Friday after a Food and Drug Administration advisory committee's negative vote on the biopharmaceutical company's Zynquista as an adjunct to ...