The firm also said this week that it plans to submit data to the FDA from an adjuvant trial of giredestrant in ER-positive, HER2-negative breast cancer.

The firms submitted data from the Phase III DESTINY-Breast05 trial comparing Enhertu to Roche's antibody-drug conjugate Kadcyla.

After a data monitoring committee saw increased risk of secondary blood cancers in the SYPHONY-1 trial, the firm will stop selling the drug for follicular lymphoma and sarcoma.

The House of Lords science and technology committee seeks answers to questions regarding the implementation of treatments like CAR T-cell and gene therapies.

The FDA approved this combination tablet in the same population late last year based on the AMPLITUDE study data.

While the US Food and Drug Administration touts new regulatory flexibility for rare disease drugs, recent rejections of ...

The FDA released a much-anticipated draft guidance on how makers of rare disease genetic medicines can leverage a platform ...

The company plans to combine the CAR designs with its in-house delivery platform to advance its in vivo CAR-M therapies toward clinical studies.

The NICE committee concluded that it needed additional data on various survival endpoints and further cost-effectiveness analyses.

Two former FDA veterans are worried that a "firewall" between politics and scientific regulatory decisions has been breached, risking the agency's reputation and leadership.

Day One received accelerated approval in the US in 2024 for Ojemda to treat pediatric low-grade glioma with a BRAF fusion or rearrangement or BRAF V600 mutation.

The firm received FDA feedback on the design of registrational studies of VS-7375, while it awaits new data for Avmapki Fakzynja.