- FDA Receives sNDA for Daratumumab Combo in Newly Diagnosed ...🔍
- FDA approves daratumumab and hyaluronidase|fihj with bortezomib ...🔍
- FDA Approves 4|Drug Combo for Newly Diagnosed Myeloma Patients🔍
- FDA Approves Daratumumab Plus VRd in Newly Diagnosed ...🔍
- Johnson & Johnson submits applications in the U.S. and EU seeking ...🔍
- DARZALEX FASPRO® 🔍
- FDA approves daratumumab and hyaluronidase|fihj for multiple ...🔍
- A Look Back at FDA News from March 2019🔍
FDA Receives sNDA for Daratumumab Combo in Newly Diagnosed ...
FDA Receives sNDA for Daratumumab Combo in Newly Diagnosed ...
Findings from the phase 3 PERSEUS trial support the supplemental New Drug Application for the daratumumab and hyaluronidase-fihj combination ...
FDA approves daratumumab and hyaluronidase-fihj with bortezomib ...
... combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in patients with newly diagnosed multiple myeloma
FDA, EMA Receive Applications for Subcutaneous Daratumumab in ...
Applications have been submitted to the FDA and EMA seeking approval for daratumumab in high-risk smoldering multiple myeloma. Advertisement.
FDA, EMA Receive Applications for Subcutaneous Daratumumab in ...
Developers Johnson & Johnson have submitted regulatory applications to the FDA and the European Medicines Agency (EMA) seeking approval of ...
FDA Approves 4-Drug Combo for Newly Diagnosed Myeloma Patients
Exciting news for newly diagnosed multiple myeloma patients! The US FDA has approved a powerful 4-drug combination therapy for frontline ...
FDA Approves Daratumumab Plus VRd in Newly Diagnosed ...
Daratumumab and hyaluronidase-fihj regimen (Darzalex Faspro) in combination with bortezomib (Velcade), lenalidomide (Revlimid), ...
Johnson & Johnson submits applications in the U.S. and EU seeking ...
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) received U.S. FDA approval in May 2020 and is approved for nine indications in multiple ...
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)
Patients will have the opportunity to receive this DARZALEX FASPRO®-based quadruplet therapy at initial diagnosis, providing them with a new ...
FDA approves daratumumab and hyaluronidase-fihj for multiple ...
for adult patients with newly diagnosed or relapsed/refractory multiple myeloma. This new product allows for subcutaneous dosing of daratumumab.
A Look Back at FDA News from March 2019 - Targeted Oncology
On March 7, 2019, a supplemental new drug application (sNDA) was submitted to the FDA seeking approval for the combination of venetoclax and ...
New Paradigm Emerging in Multiple Myeloma Therapy - OncLive
In May 2013, single-agent daratumumab received a breakthrough therapy designation from the FDA as a treatment for patients with multiple myeloma ...