by Madaline Spencer | Mar 27, 2026
Paul Romness, CEO of OS Therapies, discusses the Plausible Mechanism Framework draft guidance and how it will affect the approval process of OST-HER2 LM for the treatment of osteosarcoma. Osteosarcoma is the most common type of bone cancer, typically occurring...
by Madaline Spencer and Joe Haddad | Mar 27, 2026
The US Food and Drug Administration (FDA) has approved Opdivo (nivolumab) with doxorubicin, vinblastine, and dacarbazine (AVD) for adult and pediatric patients 12 years and older with previously untreated, Stage 3 or 4 classical Hodgkin lymphoma (cHL). The approval...
by Madaline Spencer | Mar 26, 2026
The US Food and Drug Administration (FDA) has approved Lynavoy (linerixibat) for the treatment of cholestatic pruritus in adult patients with primary biliary cholangitis (PBC). PBC is a chronic, progressive autoimmune liver disease in which the bile ducts become...
by Madaline Spencer | Mar 24, 2026
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for mavorixafor (Xolremdi) for the treatment of WHIM syndrome in patients aged 12 years and older. WHIM syndrome is...
by Madaline Spencer | Mar 23, 2026
Geraldine Bliss, Co-Founder and President of CureSHANK, and Jenny Graham Beeson, Board Member for CureSHANK, discuss clinical research in Phelan-McDermid syndrome (PMS) and the Start Genetic initiative. PMS is a chromosome disorder caused by deletions at...
