Vertex Pharmaceuticals' non-opioid pain medication gets FDA approval
A non-opioid pain medication made by Vertex Pharmaceuticals has received approval for adults from the Food and Drug ...
FDA approves new pain medication as an alternative to opioids: What to know about Journavx
The FDA on Thursday approved a new class of pain medication that provides an alternative to opioids. It will be sold under ...
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 ...
FDA Approves the First Non-Opioid Pain Drug in 20 Years
The prescription pills, sold under the brand name Journavx and made by Vertex Pharmaceuticals, are taken twice a day and ...
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FDA Expands Label of AZN's Enhertu for New Breast Cancer Indication
AstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application ...
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FDA Approves First HER2-Ultralow Companion Diagnostic, Expanding Treatment Eligibility
Roche’s PATHWAY HER2 (4B5) test helps identify patients with HER2-ultralow breast cancer, who may be eligible for targeted ...
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FDA Approves Supplemental Biologics License Application for Intravenous Maintenance Dosing of Leqembi in Alzheimer Disease
The FDA has approved a Supplemental Biologics License Application (sBLA) for intravenous maintenance dosing of Eisai and Biogen’s Leqembi (lecanemab) once every four weeks for patients with early ...
FDA approves Eisai, Biogen’s sBLA for lecanemab-irmb IV dosing
Eisai (ESAIY) and Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has approved the Supplemental Biologics License ...
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FDA Reviews Golimumab Biosimilar, Samsung Biologics Hits Record Sales, Japan Approves Stelara Biosimilar
The FDA accepted applications for a golimumab biosimilar, while Samsung Biologics reported record sales, and a Japanese ...
Thinking of getting a nonsurgical cosmetic procedure with dermal filler? Here’s what you need to know.
Dermal filler injections can be dangerous if they're not done by licensed medical practitioners. Here's how the FDA ...
FDA Approves LEQEMBI® (lecanemab-irmb) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease
INDICATION LEQEMBI ® [ (lecanemab-irmb) 100 mg/mL injection for intravenous use] is indicated for the treatment of Alzheimer’s disease (AD). Treatment with LEQEMBI should be initiated in patients with ...