News Amgen, AZ will pilot FDA's real-time clinical trial plan The FDA has published a plan to allow data from clinical trials to be reported to the agency as they occur in real time.
News GSK eyes October FDA verdict on chronic hep B drug GSK's antisense-based drug for chronic hepatitis B (CHB), bepirovirsen, has started a speedy FDA review that should deliver a verdict by 26th October.
News FDA declines to approve AbbVie's Botox follow-up AbbVie's bid to bring a rapid and shorter-acting botulinum toxin product to the US market has been knocked back by the FDA.
Market Access Fighting fake GLP-1s to protect patients & preserve trust Counterfeit drug promotion is a patient safety, brand equity, and public trust issue.
News FDA delays decision on Sanofi's subcutaneous Sarclisa The FDA has extended its review of a new version of Sanofi's multiple myeloma Sarclisa that could help narrow the gap with arch-rival Darzalex.
News FDA kicks off review of Roche's Gazyva for wider lupus use Roche could be just months away from an FDA approval of Gazyva as the first anti-CD20 therapy for systemic lupus erythematosus.
News Parexel buys Vitrana to boost patient safety toolkit Contract research organisation Parexel has bought Vitrana and its AI-powered pharmacovigilance platform for an undisclosed sum.
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