Sangamo Therapeutics recently reported detailed data from its completed registrational Phase 1/2 STAAR study of isaralgagene ...

In certain cases, regulators will now be open to clearing therapies based on their ability to eliminate tumor cells, a change ...

On January 12, NP-G2-044 (Prilukae), a novel oral fascin inhibitor earned ODD for the treatment of pancreatic cancer. This designation covers the use of the agent as monotherapy and in combination ...

The findings show diligence from the FDA and a need for clinicians to discuss risks, benefits, and unknowns with patients before using drugs with accelerated approval.

In patients naïve to HER2-targeted therapy, the objective response rate was 71% with a median duration of response of 9.2 months. The Food and Drug Administration (FDA) has granted accelerated ...

After a short delay and concerns of potential intervention from senior officials, the FDA has issued a draft guidance for the industry on the potential use of minimal residual disease (MRD) and ...

(RTTNews) - Roche (RHHBY, RO.SW, ROG.SW) announced that the FDA has approved CD20xCD3 bispecific Lunsumio VELO or mosunetuzumab, as a subcutaneous formulation, for the treatment of adult patients with ...

Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical, Co. Ltd. (Otsuka) today announce the U.S. Food and Drug Administration (FDA) has granted accelerated approval of ...

New draft guidance from the FDA on multiple myeloma endpoints reflects the new technology available to assess disease and how patient journeys have changed with better treatments.

The FINANCIAL — Roche announced on April 12 that the U.S. Food and Drug Administration (FDA) granted accelerated approval to Venclexta (venetoclax) for the treatment of people with chronic lymphocytic ...