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FDA has granted priority review to Johnson & Johnson's Rybrevant Faspro for head and neck cancer, backed by 42% ORR in the OrigAMI-4 trial.

Johnson & Johnson has entered a collaboration and equity investment agreement with Sail Biomedicines to advance in vivo CAR-T therapies for immune-mediated diseases, securing an exclusive option to acquire the company for $2.58 billion.

Today's episode explores how FDA expedited pathways continue to shape advanced therapy development, from new RMAT designations for cell and gene therapies to an advisory committee review that underscores the agency's evolving expectations for clinical evidence.

Aprea Therapeutics CEO Dr Oren Gilad discusses ASCO 2026 data for WEE1 inhibitor APR-1051 and the company's precision oncology strategy while at BIO 2026.

Allogene's cema-cel has received FDA RMAT and fast track designations for first-line consolidation therapy in high-risk large B-cell lymphoma.

The FDA has granted Regenerative Medicine Advanced Therapy designation to Ocugen's OCU410, a one-time AAV gene therapy for geographic atrophy secondary to dry age-related macular degeneration, based on Phase 2 data showing a statistically significant reduction in lesion growth.

FDA staff have questioned RP1's melanoma trial data ahead of a July 30, 2026 advisory committee vote, causing Replimune shares to fall 30%.

Carrie Bracco, head of business development, US, Novartis Contract Manufacturing, explains why manufacturing flexibility is becoming as important as capacity for emerging biotechnology companies navigating biopharmaceutical development and contract manufacturing decisions.

Paul Romness, chair, chief executive officer, and president of OS Therapies, discusses how advances in linker chemistry, payload design, and evolving regulatory approaches could shape the next generation of antibody–drug conjugates for oncology.

AbelZeta has received FDA RMAT clearance for a registrational phase 2 trial of its bispecific CAR-T therapy, C-CAR168, in refractory lupus nephritis.

GSK will invest £400 million (US$532 million) in a new Cambridge, UK, R&D center, relocating from Stevenage amid second quarter earnings and a cost-savings plan.

Today's podcast episode highlights three stories shaping the future of antibody therapeutics, from a next-generation bispecific ADC advancing toward the clinic, to a new biologics innovation consortium in China, to a major acquisition expanding an autoimmune pipeline.

Brandon Pence, FUJIFILM Biosciences' president and chief operating officer, identifies cell consistency and viral vector capsid fill ratios as the 2 most critical unresolved hurdles in CGT manufacturing scale-up.