Merck and Daiichi Sankyo’s I-DXd trial faces FDA hold due to unexpected death rates in small cell lung cancer study.
Browsing: Regulatory & Approvals
Regulatory updates, drug approvals, submissions, and compliance developments from authorities like FDA, EMA, and others.
Novo Nordisk FDA approval for oral Wegovy marks a significant step in the obesity drug market, outpacing competitors.
Cytokinetics FDA approval marks its first drug clearance, challenging Bristol Myers’ Camzyos in the heart drug market.
Novo Nordisk files for CagriSema approval, competing with Eli Lilly’s obesity drug. Merck and Pfizer succeed in bladder cancer study.
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.