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Neurelis Announces FDA Approval for Immediate Use Seizure Medication Valtoco (diazepam nasal spray) in Ages 2 to 5 Years
San Diego, CA – April, 16, 2025 – Neurelis, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved Valtoco (diazepam...
Mirum’s Livmarli Now FDA Approved in Tablet Formulation
(BUSINESS WIRE) April 14, 2025 -- Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that the U.S. Food and Drug Administration (FDA) has approved...
FDA Grants Interchangeable Designation to Yuflyma (adalimumab-aaty), Celltrion's Biosimilar to Humira (adalimumab)
Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated Yuflyma (adalimumab-aaty), as an interchangeable biosimilar...
FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) as a First-Line Treatment for Unresectable or Metastatic Hepatocellular Carcinoma
(BUSINESS WIRE) April 11, 2025 -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo®...
FDA Approves Jobevne (bevacizumab-nwgd), a Biosimilar to Avastin
BRIDGEWATER, New Jersey and BENGALURU, Karnataka, India, April 10, 2025 -- Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE code: 532523, NSE:...
FDA Approves Self-Injection of Vyvgart Hytrulo
The U.S. Food and Drug Administration has approved a self-injection version of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment...
CDC: Autism Prevalence Was 32.2 Per 1,000 8-Year-Olds in 2022
The prevalence of autism spectrum disorder (ASD) was 32.2 per 1,000 children aged 8 years across 16 sites in the United States in 2022, according to research...
Flares Occur Frequently in Generalized Pustular Psoriasis
Patients with generalized pustular psoriasis (GPP) experience frequent flares, and treatment alterations of off-label agents are frequently observed, according...
Circulating Tumor DNA Can ID Outcomes for Patients With Melanoma
Droplet digital polymerase chain reaction (PCR) measurements of cell-free, circulating tumor DNA (ctDNA) can identify patients with melanoma and a high...
Certain Combinations of Food Additives May Increase Risk for Type 2 Diabetes
Two widely consumed food additive mixtures may increase type 2 diabetes incidence, according to a study published online April 8 in PLOS Medicine. Marie...
New Trial Will Test Gene-Edited Pig Liver for Sudden Liver Failure Patients
A new clinical trial will soon test if a pig liver can help people whose own livers have suddenly stopped working. The hope? That animal organs can temporarily...
Autism Rates Rise Again, Now Affecting 1 in 31 U.S. Children
WEDNESDAY, April 16, 2025 — Autism diagnoses are on the rise again, with about 1 in 31 U.S. children affected, according to a new report from the...
Arkansas, Indiana Push to Ban Candy, Soda From SNAP Program
WEDNESDAY, April 16, 2025 — Republican governors in Arkansas and Indiana are asking the federal government for permission to ban soda and candy purchases...
Repurposing Blood Pressure Drug Reserpine May Prevent Vision Loss in Inherited Blinding Diseases
New studies in rats suggest the drug reserpine, approved in 1955 for high blood pressure, might treat the blinding disease retinitis pigmentosa. No therapy...
Precision BioSciences Receives U.S. FDA Fast Track Designation for PBGENE-HBV, a First-In-Class Gene Editing Therapy Designed to Eliminate the Root Cause of Chronic Hepatitis B
(BUSINESS WIRE)--Apr. 15, 2025-- Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS®...
FDA Warns Consumers Not to Use Counterfeit Ozempic (semaglutide) Found in U.S. Drug Supply Chain
FDA was notified by Novo Nordisk on April 3, 2025, that several hundred units of counterfeit Ozempic (semaglutide) injection 1 mg were in the U.S. drug...
How Savvy Habits May Help Head Off Dementia
From slurping daily spoonfuls of fish oil to giving up alcohol, lifting weights and playing word games, older Americans think just about anything that...
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Recently added consumer and prescribing information: Miudella, Opdivo Qvantig, Alyftrek, Crenessity, Ensacove, Steqeyma, Yesintek, Revuforj, Danziten, Aucatzyl
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Latest FDA New Drug Approvals
- Jobevne Jobevne (bevacizumab-nwgd) is a vascular endothelial growth factor inhibitor biosimilar to Avastin used for the treatment of colorectal...
- Vanrafia Vanrafia (atrasentan) is an endothelin A receptor antagonist used for proteinuria reduction in primary immunoglobulin (IgA) nephropathy.
- Qfitlia Qfitlia (fitusiran) is an antithrombin-directed small interfering ribonucleic acid for the prophylactic treatment of people with hemophilia...
Drugs in Development (Not yet approved)
- Yutrepia Yutrepia (treprostinil) is an inhaled dry powder formulation of treprostinil tentatively approved for the treatment of pulmonary arterial...