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FDA Approves Niktimvo (axatilimab-csfr) for the Treatment of Chronic Graft-Versus-Host Disease (GVHD)
WILMINGTON, Del. & WALTHAM, Mass.--(BUSINESS WIRE)--Aug. 14, 2024-- Incyte (Nasdaq:INCY) and Syndax Pharmaceuticals (Nasdaq:SNDX)...
FDA Grants Accelerated Approval for Livdelzi (seladelpar) for the Treatment of Primary Biliary Cholangitis
(BUSINESS WIRE) August 14, 2024 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated...
FDA Approves Nemluvio (nemolizumab) for the Treatment of Adult Patients with Prurigo Nodularis
Zug, Switzerland – August 13, 2024 – Galderma today announced that the U.S. Food and Drug Administration (FDA) has approved Nemluvio (nemolizumab)...
FDA Approves Yorvipath (palopegteriparatide) for the Treatment of Hypoparathyroidism in Adults
Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has approved Yorvipath (palopegteriparatide; developed...
FDA Approves Enzeevu (aflibercept-abzv), a Biosimilar to Eylea
Basel, August 12, 2024 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, today announced that the US Food and...
Mosquitos: Get Them to Buzz Off
It's that time of year when mosquitoes are at their peak, buzzing around barbecues and stinging at will.But you don't have to become their next victim,...
Automated Multiorgan CT Can Predict Diabetes, Other Conditions
Automated multiorgan computed tomography (CT), including visceral fat, can predict diabetes and associated cardiometabolic conditions, according to a study...
Skin of Color Has More Adverse Events From Sclerotherapy
Patients with skin of color may experience more adverse events from sclerotherapy, according to a study published online July 26 in the Journal of...
Acceptable Liver Transplant Outcomes Seen After ICI Therapy for Liver Cancer
For patients with hepatocellular carcinoma (HCC), immune checkpoint inhibitor (ICI) use prior to liver transplant (LT) does not worsen outcomes, according...
FDA Authorizes First At-Home Test for Syphilis
As syphilis cases surge throughout the United States, the U.S. Food and Drug Administration on Friday approved the first diagnostic at-home test to spot...
Parents' Excessive Smartphone Use Could Harm Children's Mental Health
A child at the dinner table talks about trouble at school or an argument with a friend, but parents aren't listening: They're checking their smartphones...
Diffusion Tensor Imaging Improves Prognostic Model for Mild TBI
For patients with mild traumatic brain injury and normal computed tomography (CT), diffusion tensor imaging (DTI) improves existing prognostic models for...
Sweden Reports First Case of New Mpox Strain as Africa Outbreak Continues
As an outbreak of a new strain of mpox continues in Africa, Sweden announced Thursday that it has confirmed the first case in that country. Known as the...
Prota Therapeutics Announces Publication in Allergy of Long-Term Peanut Allergy Study Confirming Clinical Remission as the Optimal Treatment Outcome
MELBOURNE, Australia, Aug. 14, 2024. Prota Therapeutics Pty Ltd (Prota), an Australian clinical-stage biotechnology company focused on the development...
Candidate Malaria Vaccine Provides Lasting Protection in NIH-Sponsored Trials
Two National Institutes of Health (NIH)-supported trials of an experimental malaria vaccine in healthy Malian adults found that all three tested regimens...
Anti-Inflammatory Diet Could Lower Your Odds for Dementia
Eating a healthy diet that dampens inflammation in the body could lower your odds for dementia, especially if you already have heart risk factors, a new...
LENZ Therapeutics Announces Submission of New Drug Application to U.S. Food and Drug Administration for LNZ100 for the Treatment of Presbyopia
LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), a late clinical-stage biopharmaceutical company focused on developing...
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Latest FDA New Drug Approvals
- Niktimvo Niktimvo (axatilimab-csfr) is a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody used for the treatment of chronic...
- Livdelzi Livdelzi (seladelpar) is a selective peroxisome proliferator-activated receptor delta (PPARδ) agonist used for the treatment of primary...
- Nemluvio Nemluvio (nemolizumab) is an interleukin-31 receptor antagonist indicated for the treatment of adults with prurigo nodularis.
Drugs in Development (Not yet approved)
- Yutrepia Yutrepia (treprostinil) is an inhaled dry powder formulation of treprostinil for the treatment of pulmonary arterial hypertension (PAH) to...
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