We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The European Commission has laid out its regulations for selecting EU member states to evaluate suspected unexpected serious adverse reactions (SUSARs) that occur in clinical trials. Read More
The FDA has submitted its user fee reauthorization letters covering prescription drugs, generics and biosimilars to lawmakers — enabling Congress to begin crafting legislation authorizing the programs for fiscal years 2023 to 2027. Read More
Could Biogen sidestep the Centers for Medicare and Medicaid Services (CMS) coverage decision that threatens to topple its longed-for Alzheimer’s treatment franchise? Read More
In a 13-to-8 vote yesterday, the Senate Health and Education, Labor and Pensions (HELP) Committee signed off on Robert Califf as the next FDA commissioner, paving the way for a full chamber vote on his nomination. Read More
In October, the European Medicines Agency recommended that the condition be added as an adverse reaction with an unknown frequency to the J&J vaccine product information. Read More
CMS’ proposal to only cover Aduhelm in clinical trials has put a big hole in Biogen’s plan to create a global Alzheimer’s disease therapy franchise. Read More
In early October, a federal appeals court ruled that the FDA incorrectly approved Ruzurgi because Catalyst Pharmaceuticals already owned the rights to the drug. Read More
Medicare will only cover Aduhelm, the controversial Alzheimer’s disease antibody, for people who are enrolled in qualifying clinical trials, the Centers for Medicare and Medicaid Services (CMS) proposed today. Read More
The FDA has lifted its clinical hold on Allogene Therapeutics’ five early-stage clinical trials of its chimeric antigen receptor T (CAR-T) therapy. Read More