Tag: Drug Approvals
FDA Approves First-in-Class Treatment for Myasthenia Gravis
Vyvgart is the first neonatal Fc receptor blocker to be approved to treat generalized myasthenia gravis in patients testing positive for AChR antibody
FDA Approves Imaging Drug That Can Help Surgeons Spot Ovarian Cancers
Drug is designed to improve surgeon's ability to detect ovarian cancer while operating on a patient
FDA Approves First Interchangeable Biosimilar for Inflammatory Diseases
Cyltezo is first interchangeable monoclonal antibody for RA, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, chronic plaque psoriasis
First Biosimilar Approved for Macular Degeneration, Other Eye Conditions
Biosimilar to Lucentis approved to treat neovascular age-related macular degeneration, macular edema, myopic choroidal neovascularization
Precedent Needed for FDA Approval Decisions When Evidence Lacking
In seven of 22 cases, approval used new interpretations of original evidence and did not require new evidence
Xywav Gets FDA Approval to Treat Rare Sleep Disorder
First drug to be approved by the agency for idiopathic hypersomnia
Enzyme Replacement Therapy Approved for Late-Onset Pompe Disease
Patients taking Nexviazyme saw improvements in respiratory function and walking distance measures
REGEN-COV Authorized for Postexposure Prophylaxis in High-Risk Individuals
Emergency use authorization indicated for those who have been exposed to SARS-CoV-2 and have an immunocompromising condition
Full Approval of Pfizer COVID-19 Vaccine Could Come in September
FDA said in a statement that its leaders recognized that full approval might counter vaccine hesitancy
Report Questions Benefit of FDA Accelerated Approval Pathway
112 of the 253 authorized drugs have not been confirmed as clinically effective; 24 of these have been on market more than five years