US FDA OKs monthly maintenance dosing for Eisai/Biogen's Alzheimer's drug
The U.S. Food and Drug Administration has approved monthly maintenance dosing for Japan's Eisai and partner Biogen's ...
Managed Healthcare Executive1 小时
FDA Approves First BTK Inhibitor as First-Line Therapy for Mantle Cell Lymphoma
The drug received accelerated approval in October 2017 as monotherapy for adults with MCL who have received at least one ...
STAT5 小时
U.S. health agencies see some chaos — but an FDA approval gets through
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pulmonologyadvisor3 天
FDA Alert: Pulmonology Drug Approvals, Recalls, and Device Updates
FDA 2025 pulmonology drug alerts, including drug approvals/warnings, vaccine approvals, and medical device recalls/updates.
Pharm Exec1 小时
FDA Approves Supplemental Biologics License Application for Intravenous Maintenance Dosing ...
Approval was based on results from multiple studies, which demonstrated a slowing of cognitive decline in patients with ...
The American Journal of Managed Care2 小时
FDA Approves New Maintenance Dosing for Lecanemab to Treat Early-Stage Alzheimer Disease
The FDA approves a new maintenance dosing regimen for lecanemab (Leqembi; Eisai) in patients with early-stage Alzheimer ...
rheumatologyadvisor5 小时
FDA Approves Marketing of Nicotine Pouches
Following an extensive scientific review, the US Food and Drug Administration has authorized the marketing of 20 ZYN nicotine pouch products.
FDA approves Leqembi four-week maintenance dosing
The FDA has approved Eisai (OTCPK:ESALF) and Biogen's (NASDAQ:BIIB) supplemental application for four-week maintenance dosing of their Alzheimer's drug Leqembi. The agency approved Leqembi to be dosed ...
FDA-approved nasal spray for severe depression can lead to remission
The Food and Drug Administration (FDA) recently approved the nasal spray Spravato for the treatment of major depression in ...
FDA approves standalone use of J&J’s ketamine-derived depression treatment
The U.S. Food and Drug Administration expanded approval for Johnson & Johnson’s nasal spray, Spravato, to allow it to be used ...
FDA approves first-of-its-kind nasal spray for severe depression
Johnson & Johnson has announced the FDA’s approval of a first-of-its-kind, esketamine nasal spray called Spravato for the ...
The FDA is about to make weight-loss drugs a lot harder to get
Lots of people are on cheaper compounded weight-loss drugs that mimic brands like Ozempic, Wegovy, and Zepbound. They're ...