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The FDA has issued a Form 483 to Advanced Accelerator Applications, citing quality and laboratory control issues observed during an inspection of the company’s sterile drug manufacturing facility in Millburn, N.J. Read More
Four rival drugmakers have joined forces to help develop digital clinical measures to assess whether new treatments for Alzheimer’s disease and related dementias are working. Read More
The FDA has advised sponsors of gene therapy products that incorporate human genome editing (GE) on how best to communicate with the FDA about products in development in a draft guidance released yesterday. Read More
Merck is stopping a phase 3 trial of its mega blockbuster anti-PD-1 therapy Keytruda (pembrolizumab) in combination with AstraZeneca’s blockbuster PARP inhibitor Lynparza (olaparib) for prostate cancer after an independent data monitoring committee recommended it do so. Read More
The European Medicines Agency (EMA) is seeking comments from the public on a draft pharmacovigilance guideline published yesterday on assessing the risk of drug-related fetal abnormalities and when to employ a pregnancy prevention program (PPM) or risk minimization measures (RMM). Read More
The FDA has sent AstraZeneca a Complete Response Letter (CRL) over its supplemental Biologics License Application (sBLA) for the company’s blockbuster Fasenra (benralizumab), as a treatment for chronic rhinosinusitis with nasal polyps (CRSwNP). Read More