FDA Grants Priority Review to Darzalex Combo for Transplant-eligible Patients
The U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental Biologics License Application (sBLA) of Darzalex (daratumumab)…
The U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental Biologics License Application (sBLA) of Darzalex (daratumumab)…
Oncopeptides is preparing to submit a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) to seek accelerated…
ALLO-715, Allogene Therapeutics‘ donor-derived CAR T-cell therapy, can trigger a durable anti-tumor response in mice with multiple myeloma, and maintain its characteristics and…
Maintenance therapy with Ninlaro (ixazomib) can prolong and boost therapeutic responses from initial treatment in multiple myeloma patients who did not undergo an…
The European Medicines Agency‘s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Celgene‘s Revlimid (lenalidomide) and…
CT053, one of CARsgen Therapeutics‘ lead CAR T-cell therapies, soon will begin clinical testing in China for the treatment of patients with relapsed…
The U.S. Food and Drug Administration has raised concerns in its newly released briefing materials over the safety and tolerability of Karyopharm Therapeutics‘ lead compound …
Celgene‘s immunomodulatory agent Revlimid (lenalidomide) significantly extended the time until disease progression in patients with smoldering multiple myeloma who were not yet experiencing any symptoms of…
Adding Darzalex (daratumumab) to the standard pre-transplant therapy for multiple myeloma significantly increased the number of patients showing no signs of cancer after…
Molecular Templates has partnered with Takeda to develop engineered toxin bodies (EBTs) — a next-generation immuno-oncology therapy that delivers toxic payloads to cancer cells — targeting the…