The FDA has expanded the TALZENNA XTANDI approval to men with HRR gene-mutated metastatic androgen pathway modulation-naïve or -sensitive prostate cancer. The decision rests on Phase 3 TALAPRO-3 data showing an estimated 52% reduction in the risk of radiographic progression or death.
Charles River, Labcorp and the FDA have signed a Research Collaboration Agreement to develop sensitive preclinical tools that quantify and rank the abuse potential of new drugs, including abuse-deterrent formulations.
Charles River Laboratories and Magellan Stem Cells announced a collaboration on Oct. 13, 2026, bringing cGMP next-generation sequencing viral safety testing to Zelestrocel, Magellan’s off-the-shelf osteoarthritis stem cell therapy candidate.
The FDA has approved Tecentriq and Tecentriq Hybreza with a fluoropyrimidine and oxaliplatin for adjuvant treatment of stage III dMMR colon cancer, based on the phase III ATOMIC trial.
The FDA has approved Tecentriq and Tecentriq Hybreza with a fluoropyrimidine and oxaliplatin for adjuvant treatment of stage III dMMR colon cancer, based on the phase III ATOMIC trial.
The Novartis Rhapsido FDA approval makes remibrutinib the first approved treatment for adults with symptomatic dermographism not controlled by H1 antihistamines. It builds on Rhapsido’s existing chronic spontaneous urticaria indication.
Eli Lilly has committed an additional $4.5 billion across two manufacturing sites in Lebanon, Indiana, taking its total Indiana capital expansion commitments since 2020 to more than $21 billion. The investment also marks the opening of Lilly Lebanon Advanced Therapies, the company’s first dedicated genetic medicine manufacturing facility.
Charles River Laboratories (NYSE: CRL) has introduced rapid cell banking programs that the company says cut cell bank production timelines by 40% against a 20-week industry standard. The offering pairs rapid microbiological and mycoplasma tests with NGS characterization through its iDTECT platform.
Eli Lilly announced the Jaypirca Approval on October 2, 2026, as the FDA cleared pirtobrutinib for adults with previously untreated CLL/SLL and no known 17p deletion.
The Roche fenebrutinib FDA filing has been accepted under priority review for relapsing and primary progressive multiple sclerosis. The application draws on the FENhance 1, FENhance 2 and FENtrepid Phase III studies.
