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.
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 ...
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.
MassDevice7d
NeurAxis wins expanded FDA clearance for non-implanted neurostim for pain relief
NeurAxis (NYSE:NRXS) announced today that the FDA granted an expanded 510(k) clearance for its IB-Stim non-implanted nerve ...
medtechdive10d
FDA clears iRhythm’s second 510(k) in response to warning letter
However, the company said it will delay a submission for its next-generation Zio cardiac monitoring system until remediation ...
MassDevice11d
FDA clears second set of changes to iRhythm Zio AT to resolve warning letter
Rhythm Technologies (Nasdaq:IRTC) announced that the FDA granted 510(k) clearance for Zio AT design modifications and ...
Pharmabiz11d
US FDA grants accelerated approval to Novartis’ Scemblix for adult patients with newly diagnosed Ph+ CML-CP
US FDA grants accelerated approval to Novartis’ Scemblix for adult patients with newly diagnosed Ph+ CML-CP: East Hanover Thursday, October 31, 2024, 12:00 Hrs [IST] Novartis an ...
Pharmaceutical Technology12d
Novartis’ Scemblix gains FDA approval for leukaemia
Novartis has received FDA accelerated approval for Scemblix (asciminib) to treat adults with newly diagnosed Ph+ CML-CP.