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 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 ...
Pharm Exec5d
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 painkiller designed to eliminate the risks of addiction associated with opioids
U.S. officials have approved a new type of pain drug designed to eliminate the risks of addiction and overdose associated ...
ABC Action News8d
Newly FDA-approved COVID-19 treatment helps protect immunocompromised
OneBlood is the first blood center to get full FDA approval to give high-titer COVID-19 convalescent plasma to those with COVID-19 who are also immunocompromised.
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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 ...
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 ...
Business Wire2d
Scholar Rock Submits Biologics License Application (BLA) to the U.S. FDA for Apitegromab as a Treatment for Patients with Spinal Muscular Atrophy (SMA)
Apitegromab has not been approved for any use by the FDA or any other regulatory agency. About the Phase 3 SAPPHIRE Trial SAPPHIRE was a randomized, double-blind, placebo-controlled Phase 3 ...
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 ...
Journey Medical Corporation: Emrosi's Launch Could Be A Turning Point
Journey Medical's future hinges on Emrosi, a new formulation of minocycline for rosacea, showing superior efficacy. Read why ...
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Motivated: Delivering Confidence with the Fastest Erectile Dysfunction Treatment
Telehealth platforms like Motivated are changing how men treat ED with its fast, affordable, and discreet online service.