Novavax Gets FDA Approval To Resume Testing Two Vaccines After Clinical Hold
Novavax said the Food and Drug Administration allowed it to continue testing a combination COVID-19-flu and standalone flu vaccine that had been put on hold.
BioPharma Dive2h
FDA approves new CAR-T competitor to Gilead’s Tecartus
Developer Autolus set a list price of $525,000 for its new cell therapy, which it will sell for a type of leukemia under the ...
precisionmedicineonline3h
Nordic Bioscience Gets FDA Letter of Support for CPa9-HNE Biomarker in IBD
The biomarker assay can be used potentially to enrich clinical trials and monitor patients' disease activity and treatment response.
STAT19h
Risk of aspiration during surgery added to GLP-1 drug labels
From STAT’s Elaine Chen: Earlier this month, the FDA updated the labels of GLP-1 drugs to warn of the risk of patients ...
Autolus wins FDA approval of Aucatzyl for acute lymphoblastic leukemia
FDA approves Autolus Therapeutics' Aucatzyl for adults with relapsed or refractory B-cell precursor acute lymphoblastic ...
JD Supra3d
FDA Approves the First Flu Vaccine for At Home Use, Providing a Needle Free Option Outside of Traditional Health Care Settings
On September 20, 2024, the U.S. Food and Drug Administration (FDA) approved the first influenza (flu) vaccine for at‑home use. The vaccine, ...
JD Supra3d
FDA Authorizes Marketing for First Combination Flu and COVID-19 At-Home Test Outside of Emergency Use
On October 7, 2024, FDA granted marketing authorization for the over‑the‑counter combination flu and COVID-19 combination test, Healgen Rapid ...
medtechdive4d
J&J wins FDA approval for Varipulse PFA system
J&J is the third medtech company to gain U.S. approval for pulsed field ablation, a new atrial fibrillation treatment seeing rapid adoption.
AskBio Receives FDA Rare Pediatric Disease and Orphan-Drug Designations for AB-1003 for the Treatment of Limb-Girdle Muscular Dystrophy Type 2I/R9
(AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that AB-1003 (also known as LION-101) has received rare pediatric disease ...
British Vogue4d
I Struggle With Thinning Hair. Here’s A Detailed Breakdown Of The Targeted Products I Swear By
“Minoxidil is one of the few FDA-approved treatments for female hair loss ... It smells amazing. Derma stamp In addition to minoxidil, you can support new growth with a derma stamp. “It’s a small, ...
360dx5d
Caris Life Sciences CDx Assay Nabs FDA Approval
The whole-exome sequencing and whole-transcriptome sequencing-based test is approved for molecular profiling of solid tumors.