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Delcath Looking For Second Chance With SPA

 
• By Lisa LaMotta

Two years after an FDA rejection sent Delcath Systems spiraling, the company has reached an agreement with the regulatory agency to move its once-rejected drug-device combo forward.

The biotech announced Jan. 19 that it has established a special protocol assessment (SPA) for its Phase III trial of...

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In Brief: Bayer Commits Up To $1.3bn For Kumquat’s KRAS G12D Inhibitor

 
• By Mary Jo Laffler

Deal Snapshot: Bayer will take over development of the asset once Kumquat completes a Phase Ia clinical trial, but the biotech firm may opt in to share US profits and losses.

Pfizer/Astellas’s Padcev Scores First Big Win In Bladder Cancer Study

 
• By Alaric DeArment

The drug, combined with Merck’s Keytruda, was successful among certain chemotherapy-ineligible MIBC patients, with another Phase III readout expected by March 2026.

Boehringer Scores First Approval For Targeted Oral Drug In HER2-Mutant NSCLC

 
• By Alaric DeArment

The US FDA approved Hernexeos for previously treated HER2-mutant NSCLC, making it the first oral option in a setting where drugs like AstraZeneca/Daiichi Sankyo’s Enhertu dominate.

Genmab/AbbVie’s Epkinly Likely To See Label Expansion After Phase III Win

 
• By Alaric DeArment

The FDA is expected to rule on the anti-CD20xCD3 bispecific combined with rituximab/lenalidomide in second-line follicular lymphoma in November.

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Genmab/AbbVie’s Epkinly Likely To See Label Expansion After Phase III Win

 
• By Alaric DeArment

The FDA is expected to rule on the anti-CD20xCD3 bispecific combined with rituximab/lenalidomide in second-line follicular lymphoma in November.

Sanofi’s Sarclisa Wins Another EU Multiple Myeloma Nod In Its Unequal Battle With J&J’s Darzalex

 
• By Sushmita Panda

The French drugmaker's anti-CD38 antibody has racked up another approval in first-line multiple myeloma, but it marks a small victory while the company develops a subcutaneous version to help level the field with J&J’s Darzalex.

Jazz’s Modeyso Approved For Rare Glioma With Expansion Targeted

 
• By Jessica Merrill

The accelerated approval came three months after Jazz completed the acquisition of Modeyso’s developer, Chimerix.