Novo Nordisk files for CagriSema approval, competing with Eli Lilly’s obesity drug. Merck and Pfizer succeed in bladder cancer study.
Browsing: Regulatory & Approvals
Regulatory updates, drug approvals, submissions, and compliance developments from authorities like FDA, EMA, and others.
Lilly obesity pill Orforglipron shows promise in a maintenance trial, potentially broadening its use in obesity treatment.
GSK asthma drug approval marks a significant milestone with FDA clearance of Exdensur for twice-yearly dosing, impacting severe asthma care.
FDA fast pass J&J for multiple myeloma regimen, impacting treatment timelines.
Praxis epilepsy drug approval filing is planned for early 2025 after collaborative discussions with the FDA. Rezolute shares fell, Centessa named a new CEO.
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.