Amylyx Pharmaceuticals, Inc.

To avoid public disagreement, US Food and Drug Administration center directors should spend more time with their staff earlier in a product’s review, outgoing Commissioner Robert Califf said. Public d

The amyotrophic lateral sclerosis (ALS) pipeline has suffered a series of setbacks recently and two separate candidates from AbbVie/Calico Life Sciences and Denali Therapeutics that have the same of m

AstraZeneca PLC ’s Imfinzi became the second cancer immunotherapy approved for perioperative use in resectable non-small cell lung cancer (NSCLC) on 15 August, despite the US Food and Drug Administrat

The first meeting of the US Food and Drug Administration’s Genetic Metabolic Diseases Advisory Committee will be heavy on temporary voting members, several of whom are veterans of the adcomm process.