Tag: Drug Approvals
Doctors Can Be Misled About FDA ‘Breakthrough’ Drug Designation
Many believe meds supported by stronger evidence than the law requires to achieve designation
FDA Approves Venclexta for CLL With 17p Deletion
Drug sanctioned for chronic lymphocytic leukemia in patients with a specific chromosomal abnormality
FDA Approves First Leadless Pacemaker
Eliminates need to repair wire lead in typical pacemakers that can malfunction
FDA Approves Inflectra as ‘Biosimilar’ to Remicade
For adults with Crohn's, rheumatoid arthritis, or psoriasis
FDA Approves First Tx for Disease Linked to Stem Cell Transplant
Hepatic veno-occlusive disease is rare, but fatal
FDA Approves Cinqair for Severe Asthma
Lab-developed interleukin-5 antagonist monoclonal antibody helps reduce blood levels of eosinophils
FDA Approves Anthim for Treating Inhalation Anthrax
Anthim, combined with certain antibacterial drugs, designed to neutralize anthrax toxins
FDA Approves Xalkori for Rare Genetic Form of Lung Cancer
Drug approval expanded to include patients with ROS1-positive NSCLC
FDA Approves Briviact for Partial Onset Seizures
Drug sanctioned for epilepsy patients aged 16 and older
FDA Approves Zepatier for Chronic Hepatitis C
Medication indicated for patients with hepatitis C virus genotypes 1 and 4 infections
