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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

FDA Approves First Biosimilar Insulin Product

Semglee (insulin glargine-yfgn) is biosimilar to and interchangeable with Lantus (insulin glargine), provides cost-effective option

FDA Head Asks for Investigation Into Alzheimer Disease Drug Approval

Request follows reports that Biogen and the FDA held off-the-books meetings before the drug's approval that may have violated FDA protocol

House Committees to Investigate New Alzheimer Disease Drug Approval

FDA approved Aduhelm earlier this month, despite advisory committee's conclusion that there was not enough evidence to support its effectiveness