LEQEMBI Intravenous Infusion Approval; Novartis...

In recent years, the healthcare and medical devices market has undergone a remarkable transformation, largely fueled by advancements in technology and growth in innovation. One of the major standout developments in the healthcare industry is the rise of the biosurgery market and the related product demand, whic...

Over the past several years, multiple myeloma treatment options have expanded widely for patients, resulting in significantly improved outcomes. The FDA approved around 16 new agents and 30 treatment regimens, transforming the multiple myeloma treatment paradigm for patients with newly diagnosed and relapsed/refrac...

Quest Diagnostics Granted FDA Breakthrough Designation for its Adeno-associated virus (AAV) Test  On August 30, 2023, Quest Diagnostics announced that its AAVrh74 ELISA assay (CDx) has been granted Breakthrough Device Designation from the US Food and Drug Administration (FDA). The enzyme-linked immunosor...

The landscape of multiple myeloma treatment has undergone a profound transformation with the advent of monoclonal antibodies (mAbs) targeting CD38. Among the notable breakthroughs, two anti-CD38 mAbs, DARZALEX (daratumumab) and SARCLISA (isatuximab-irfc), have been approved for clinical use. These groundbreaking mu...

FDA Approves Bristol Myers Squibb’s Reblozyl as First-Line Treatment of Anemia in Adults with Lower-Risk MDS Who May Require Transfusions Bristol Myers Squibb announced that the Food and Drug Administration (FDA) has approved Reblozyl® (luspatercept-aamt) for the treatment of anemia in adult patients with very l...

Step aside, CAR-Ts; with three FDA approvals, the class of bispecific antibodies has begun to take on the relapsed/refractory multiple myeloma treatment segment. Currently, the US Food and Drug Administration (FDA) has authorized 10 bispecific antibodies and one bispecific molecule, the majority of which are a...