Shorla Oncology Announces FDA Acceptance of NDA for Novel Treatment for Breast, Ovarian Cancer
January 10th 2024The novel therapy in development to treat breast cancer and ovarian cancer is a formulation of a well-established freeze-dried powder medication that has been in use dating back to the 1950s.
Astellas Pharma Issued Complete Response Letter for Zolbetuximab for GEJ Adenocarcinoma
January 9th 2024Astellas said it will work closely with the FDA and a third-party manufacturer to develop a timeline that will quickly resolve feedback from the complete response letter to a Biologics License Application for zolbetuximab.
sBLA for Tivdak Granted FDA Priority Review for Recurrent, Metastatic Cervical Cancer
January 9th 2024Tivdak (tisotumab vedotin-tftv), an antibody drug conjugate, was granted accelerated approval by the FDA in September 2021 for patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy.
Chronic Myeloid Leukemia Treatment Combo Shows Promise in Phase III Trial
January 8th 2024Scemblix (asciminib) was approved by the FDA in October 2021 for patients with chronic phase chronic myeloid leukemia previously administered two or more tyrosine kinase inhibitors and for adults with chronic phase chronic myeloid leukemia with the T315I mutation.
Merck Highlights Robust Oncology, Hematology Pipeline With Four Agents in Phase III Trials
January 5th 2024Trials will evaluate four novel agents for cancers that include essential thrombocythemia, chronic lymphocytic leukemia, small lymphocytic lymphoma, non-small cell lung cancer, endometrial carcinoma, and metastatic castration-resistant prostate cancer.
Eli Lilly Announces New Telehealth, Home Delivery Option for Popular Weight Loss Drug
January 5th 2024LillyDirect will facilitate access to medications by connecting patients with independent telehealth providers, bypassing the need to obtain a prescription from a physician and then going to a pharmacy to fill it.