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

ProKidney Corp. targets diabetic CKD with Rilparencel and expects Q2 2027 eGFR slope data for accelerated approval. Find out ...

After a short delay and concerns of potential intervention from senior officials, the FDA has issued a draft guidance for the industry on the potential use of minimal residual disease (MRD) and ...

The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual ...

New draft guidance from the FDA on multiple myeloma endpoints reflects the new technology available to assess disease and how patient journeys have changed with better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

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 ...

Early access to new cancer drugs, granted accelerated approval by the U.S. Food and Drug Administration (FDA), has provided mixed benefits for patients while costing Medicare billions of dollars, ...

(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 ...