Regulatory
The FDA approved Eisai and Biogen’s lecanemab (Leqembi) Friday afternoon. It is the second anti-amyloid antibody to be approved for Alzheimer’s disease in two years.
BrainStorm Cell Therapeutics appoints a new co-CEO as it prepares for a January 11th Type A meeting for ALS hopeful NurOwn.
Two documents recently came to light: first, the results of a congressional investigation into the approval of Aduhelm; second, a revised clinical trial consent form for lecanemab.
Verona Pharma’s COPD candidate hits the mark in late-stage testing.
The FDA placed a clinical hold on Entrada’s experimental DMD candidate.
The FDA lifted its partial clinical hold on bluebird’s experimental sickle cell disease gene therapy for patients younger than 18.
The FDA’s Cardiovascular and Renal Drugs Advisory Committee stood against Cytokinetics, Inc., finding that the benefits of its heart failure hopeful didn’t outweigh its risks.
As 2022 comes to its conclusion, the FDA has a handful of Prescription Drug User Fee Amendments still to wrap up. Here’s a look at that and more.
Monday, Verve Therapeutics revealed that the FDA has officially requested several buckets of additional safety information to lift the hold on its lead candidate, VERVE-101.
The FDA has lifted its clinical hold on Beam Therapeutics’ BEAM-201 and cleared the way for an Investigational New Drug Application, the company announced Friday.
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