Serono Luveris review
Executive Summary
Serono's NDA (21-322) for recombinant luteinizing hormone product Luveris (lutropin alpha for inj.) will be reviewed by FDA's Reproductive Health Drugs Advisory Committee on Sept. 30 for concomitant administration with recombinant human follicle stimulating hormone for the induction of ovulation in infertile women with severe luteinizing hormone or follicle stimulating hormone deficiency. The meeting on both days will begin at 8:30 a.m. at the Hilton in Gaithersberg, Md. [To 1watch a webcast or live video of these meetings, go to FDAAdvisoryCommittee.com]....
You may also be interested in...
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.
GLP-1 Coverage Restrictions In Medicare Part D Surge As Demand For Obesity Drugs Grows
A major shift from unfettered coverage to prior authorizations was recorded by MMIT over the past year for the leading GLP-1/GIP agonist diabetes drugs. Public interest in using the drugs off label for weight loss drove the change.
Roche Gets Adjuvant ALK+ Lung Cancer To Itself With Alecensa Approval
The US FDA cleared Roche’s supplemental approval request for ALK inhibitor Alecensa in ALK-positive non-small cell lung cancer following tumor resection.