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.

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.

NEW YORK – Servier is acquiring Day One Biopharmaceuticals in a deal worth approximately $2.5 billion that is expected to bolster Servier's portfolio of targeted oncology therapeutics, the firms ...

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

NEW YORK – Allarity Therapeutics said on Friday it has closed a $20 million non-convertible debt financing transaction with venture capital firm Streeterville Capital. The financing is structured as a ...

The FDA released a much-anticipated draft guidance on how makers of rare disease genetic medicines can leverage a platform ...

NEW YORK – Verastem Oncology has laid out a new registrational development pathway for the KRAS G12D inhibitor VS-7375 in pancreatic, colorectal, and non-small cell lung cancer after feedback from ...