AstraZeneca

The FDA approved AstraZeneca’s benralizumab (Fasenra) for adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), based on the MANDARA phase 3 trial. The study showed benralizumab was noninferior to mepolizumab in achieving remission and allowed more patients to taper off corticosteroids. Benralizumab is now indicated for EGPA treatment, with a recommended dose of 30 mg every 4 weeks.

FDA approves AstraZeneca's Fasenra for EGPA, based on MANDARA trial data showing 60% remission and 41% OCS tapering, comparable to GSK's Nucala.

Kyverna appoints Warner Biddle as CEO, Christi Shaw to board. Regenxbio welcomes Mitchell Chan as CFO. Mirador Therapeutics appoints Gregg Gilbert as CFO.

Novartis' Kisqali gets FDA approval for early-stage breast cancer; GSK's vaccines for RSV and shingles co-administered effectively; Novo Nordisk partners with NanoVation for genetic therapies; AstraZeneca's Mene Pangalos joins Omega Funds; Serán Biosciences secures $200M for new facility; Boehringer Ingelheim's nerandomilast shows success in Phase 3 IPF trial.

The FDA has approved benralizumab (Fasenra) for eosinophilic granulomatosis with polyangiitis (EGPA) in adults, making it the second treatment option in the US. The approval was based on the phase 3 MANDARA trial, which showed benralizumab achieved remission and allowed steroid tapering in EGPA patients. The therapy's safety profile was consistent with previous findings.

Durvalumab with tremelimumab-actl improved overall survival in unresectable hepatocellular carcinoma, reducing death risk by 24% vs. sorafenib. In muscle-invasive bladder cancer, durvalumab with chemotherapy reduced disease progression risk by 32% and death risk by 25% compared to neoadjuvant chemotherapy.

AstraZeneca's FASENRA® (benralizumab) approved in the US for treating adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). Approval based on MANDARA Phase III trial results, showing FASENRA's efficacy and safety comparable to mepolizumab. FASENRA helps patients achieve remission and taper off oral corticosteroids.

Fasenra approved in the US for eosinophilic granulomatosis with polyangiitis; MANDARA trial showed nearly 60% of patients achieved remission and 41% fully stopped taking oral corticosteroids.