API issues delay drug approval

Deficiencies at a manufacturing facility are holding up FDA approval of the antidepressant Trazodone. Labopharm, its maker, says its API manufacturer, Angelini, has said that the FDA concerns are "not critical." Article

Webinar

Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.