Advertisement
Home Tags Drug Approvals

Tag: Drug Approvals

FDA Approves First-in-Class Treatment for Myasthenia Gravis

0

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

0

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

0

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

0

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

0

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

0

First drug to be approved by the agency for idiopathic hypersomnia

Enzyme Replacement Therapy Approved for Late-Onset Pompe Disease

0

Patients taking Nexviazyme saw improvements in respiratory function and walking distance measures

REGEN-COV Authorized for Postexposure Prophylaxis in High-Risk Individuals

0

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

0

FDA said in a statement that its leaders recognized that full approval might counter vaccine hesitancy

Report Questions Benefit of FDA Accelerated Approval Pathway

0

112 of the 253 authorized drugs have not been confirmed as clinically effective; 24 of these have been on market more than five years