
The FDA will increase its flexibility on CMC requirements for cell and gene therapies to speed their development and better support BLA planning.

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The FDA will increase its flexibility on CMC requirements for cell and gene therapies to speed their development and better support BLA planning.

A BLA for ivonescimab plus chemotherapy in EGFR-mutant NSCLC following treatment with a third-generation EGFR TKI has been submitted to the FDA.

Brian Slomovitz, MD, discusses key trials and surgical advances for patients with ovarian cancer.

FDA announces new CRL for tabelecleucel in EBV+ Post-Transplant Lymphoproliferative Disease.

Experts in the field of CLL/SLL discussed the role of BTK inhibitors and degraders in R/R CLL/SLL during an OncLive Scientific Interchange and Workshop.

Atezolizumab plus bevacizumab could yield superior outcomes compared with TACE in intermediate-stage HCC.

The top 5 OncLive TV videos of the week cover insights in lung cancer, bladder cancer, gastrointestinal cancer, and multiple myeloma.

A rusfertide NDA for polycythemia vera has been submitted to the FDA, a tafasitamab combination boosts PFS over R-CHOP in DLBCL, and more.

Results from ReFocus showed a manageable safety profile and positive antitumor activity for lirafugratinib in FGFR2-mutated cholangiocarcinoma.

Neoadjuvant tislelizumab plus chemoradiotherapy yielded improved response rates in gastric cancer and gastroesophageal junction adenocarcinoma.

Adjuvant pembrolizumab did not improve RFS vs placebo in HCC following complete radiological response after surgical resection or local ablation.

Zolbetuximab plus chemotherapy delivered maximal clinical benefits when AEs were managed effectively in CLDN18.2-positive advanced gastric/GEJ cancer.
