Posts

FDA Approves Opdivo (Nivolumab) for Classical Hodgkin Lymphoma Indications

On March 20, 2026, the FDA approved Opdivo (nivolumab) in combination with doxorubicin, vinblastine, and dacarbazine (AVD) for adult and pediatric patients 12 years and older with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL) 5 The FDA approval was based on the Phase 3 SWOG 1826 study, which demonstrated a 58% reduction in the risk of disease progression or death (Hazard Ratio 0.42) 2 4 The SWOG 1826 study showed statistically significant improvement in progression-free survival for patients receiving Opdivo plus AVD compared with the standard of care BV-AVD 2 After a median follow-up of 36.7 months, the median overall survival had not been reached in either treatment arm, with only 9 deaths (1.8%) in the Opdivo plus AVD arm versus 17 deaths (3.4%) in the BV plus AVD arm 2 This represents the first immunotherapy combination approved in the U.S. for previously untreated advanced classical Hodgkin lymphoma in adults and pediatric patients ages 12 and older...

Karyopharm Expects Phase 3 SENTRY Trial Data in Myelofibrosis by March 2026

ImmunityBio Faces FDA Warning Letter Over Anktiva Promotions in TV Ad and Podcast Episode

Shionogi to Acquire Apnimed's 50% Stake in Sleep Science Joint Venture for $100M Upfront

Insmed's Arikayce Achieves Phase 3 Success in MAC Lung Disease, Paving Way for Label Expansion and Potential Blockbuster Status

Apogee Therapeutics' Phase 2 Data Positions Zumilokibart (APG777) as Convenient Alternative to Dupixent and Ebglyss in Eczema Treatment

Sanofi's $180 Million Investment in Kali Therapeutics for T-Cell Engager Development

Novartis Commits $480M to Expand Manufacturing and R&D in China Following AstraZeneca and Lilly

Gilead Acquires Ouro Medicines for Up to $2.18 Billion to Advance T Cell Engager Autoimmune Therapies

BioStem Appoints Jodi Ungrodt to Board of Directors as Audit Committee Chair

Idorsia Announces Nomination of Three Candidates for Board of Directors Election

Trump Administration's Drug Pricing Reforms and Pharmaceutical Industry Response in 2026

Oryon Cell Therapies Emerges With $42M for Autologous Neuron Replacement Therapy in Parkinson's Disease