The new label for Alecensa makes it the first targeted treatment available after surgery for people with ALK-positive lung tumors, who are at high risk for brain metastases.
With the FDA nod, Alecensa becomes the second molecularly targeted therapy to move into the adjuvant setting for non-small cell lung cancer.
The health regulor has required related updates to other sections of the label such as warnings and precautions, ...
Abecma had previously been approved by the FDA for patients who received at least four prior lines of therapy. The approval, based on findings from the phase 3 KarMMa-3 trial, makes Abecma earlier for ...
On April 3, 2024 FDA approved Zevtera (ceftobiprole medocaril sodium for injection) as a treatment for three types of bacterial infections: adults with Staphylococcus aureus bloodstream infections ...
96 shots in 41 seconds: Seatbelt violation leads to death of Black Chicago motorist Common over-the-counter medicine linked to increased dementia risk Boeing 737 Max diverts to Idaho after in ...
The U.S. Food and Drug Administration (FDA) has cleared the first prescription digital therapeutic authorized for the adjunctive treatment of major depressive disorder (MDD) symptoms. The approval ...
Peter Kim, director of the Division of Anti-Infectives in the FDA's Center for Drug Evaluation and Research, said, "The FDA is committed to fostering new antibiotic availability when they prove to ...
opens new tab antibiotic for bacterial infections including multidrug-resistant strains, the FDA said on Wednesday. The Switzerland-based company was seeking approval of its antibiotic ...
The Sepsis ImmunoScore was approved through the agency’s De Novo pathway, the process the FDA uses for novel medical devices. Poole said the company plans to sell the Sepsis ImmunoScore at ...
London: The U.S. FDA approved Vanda Pharmaceuticals' drug to treat manic and mixed episodes associated with a type of bipolar disorder, the company said on Tuesday, marking the second approval for ...