Praxis epilepsy drug approval filing is planned for early 2025 after collaborative discussions with the FDA. Rezolute shares fell, Centessa named a new CEO.
Browsing: Regulatory & Approvals
Regulatory updates, drug approvals, submissions, and compliance developments from authorities like FDA, EMA, and others.
AC Immune Parkinson’s drug shows positive data, prompting regulatory feedback request. Shares rise by double-digits.
FDA Approves Augmentin XR, marking the first drug in the National Priority Voucher program, enhancing antibiotic availability in the US.
Vertex CRISPR therapy demonstrates early success in children with sickle cell and thalassemia, potentially expanding its market reach.
Praxis shares rise 40% following positive updates on two drugs, while Bristol Myers’ Breyanzi gains approval for a fifth cancer indication.
CDC panel delays vote on hepatitis B vaccine for newborns, impacting public health.
• CDC panel delays decision on hepatitis B vaccine.
• Vote affects millions of newborns annually.
• Public health implications are significant.
FDA chiefs critique plans to toughen vaccine standards, impacting COVID-19 protocols.
UniQure Huntington’s gene therapy faces challenges as FDA deems current data insufficient for approval, affecting market outlook.
Capricor Duchenne cell therapy shows positive results, potentially reversing FDA rejection and quadrupling shares.
FDA animal testing guidance reduces non-human primate use, aiding U.S. drugmakers amid global competition.