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In its 2022 Focus Areas of Regulatory Science report released last week, the FDA adds to its list of regulatory priorities research efforts in oncology and rare disease. Read More
Roche is acquiring Good Therapeutics for $250 million in upfront cash, gaining Good’s conditionally active biologics (CAB) to create new immunotherapies for treating cancer. Read More
In just six pages of final guidance released today, the FDA lays out exactly when and how sponsors should include real-world data and real-world evidence (RWD/RWE) in applications for investigational and new drugs, as well as biologics licenses. Read More
Two late-breaking phase 3 studies highlighted advances in breast and colorectal cancer at the annual meeting of the European Society of Medical Oncology in Paris this week. Read More
An FDA advisory committee surprised observers on Wednesday night, voting 7-2 to endorse Amylyx Pharmaceuticals’ amyotrophic lateral sclerosis (ALS) drug despite FDA doubts and the committee’s own rejection of the drug six months earlier. Read More