Cancer

FDA clears Accord’s first fully in-house biosimilars, with a US launch planned for its denosumab biosimilars in 2026.

The company plans to take IGV-001 to the FDA after the mid-stage trial showed a more than six-month improvement in overall survival compared with placebo.

The US FDA’s accelerated approval makes sevabertinib the second drug for that patient segment after BI’s Hernexeos, which won accelerated approval in August.

The European Medicines Agency has begun evaluating the EU marketing applications for a new batch of drugs, including products from Incyte, Sanofi and Novo Nordisk that target hidradenitis suppurativa, rabies and hemophilia A, respectively.

Sichuan Biokin Pharmaceutical's BMS-partnered bispecific antibody-drug conjugate iza-bren had met both endpoints of PFS and OS in a China-only Phase III trial for the second-line treatment of esophageal squamous cell carcinoma.

The company announced topline results from its Phase III trial in gastroesophageal adenocarcinoma and plans to seek US FDA approval in the first half of 2026.

While the European Medicines Agency’s human medicines committee voted in favor of EU approval for 10 new products, it reaffirmed its previous decision not to grant Aqneursa new active substance status.

The US FDA approved the menin inhibitor for NPM1-mutant relapsed/refractory acute myeloid leukemia.

The EMA has scheduled oral explanation meetings this week for Anavex’s blarcamesine and three other products that are nearing the end of the regulatory review cycle. These meetings usually represent the final chance for sponsors to persuade the agency that their product merits approval.

Byterna, Starna, Vivacta and DeliNova ride surging investor sentiment on in vivo CAR-T assets to secure venture funding.

A long time on the ropes, the US firm is now well-financed to advance potential candidates for essential thrombocythemia and myelofibrosis into the clinic.

The PEAK study showed a high median progression-free survival and objective response rate in second-line disease for bezuclastinib combined with sunitinib.