Johnson & Johnson MedTech receives IDE approval for Ottava system
Johnson & Johnson MedTech announced that the U.S. Food & Drug Administration has approved the Ottava robotic surgical system ...
US FDA declines full approval for Intercept's liver disease drug
The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...
Business Insider17h
Autolus Therapeutics Gains FDA Approval for AUCATZYL®
Autolus Therapeutics ( (AUTL)) has provided an update. Autolus Therapeutics plc has achieved FDA approval for AUCATZYL®, a treatment for relapsed and refractory B-cell acute lymphoblastic leukemia, ...
Business Wire1d
Arcturus Therapeutics Receives Clearance from FDA to Begin H5N1 Pandemic Flu Vaccine Clinical Trial
mRNA drug substance along with drug product manufacturing expertise. Arcturus developed KOSTAIVE®, the first self-amplifying messenger RNA (sa-mRNA) COVID vaccine in the world to be approved. Arcturus ...
BioPharma Dive1d
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 ...
precisionmedicineonline1d
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.
WATTAgNet6d
Histomonosis transmission insights could improve treatment
There are currently no approved treatments to prevent, treat or control histomonosis, also known as blackhead disease or ...
The American Journal of Managed Care15d
FDA Approves New Abuse-Deterrent Alternative for Severe Pain Management
SentryBond technology could potentially extend to other medications, though FDA approval is pending. The FDA has approved oxycodone hydrochloride (RoxyBond) for the management of severe pain when ...
Complex15d
Logan Paul Defends Lunchly Brand Against Fake FDA Recall and Mold Allegations: 'The Ops Are Gonna Have to Try Harder'
despite a source at the FDA confirming to TMZ last week that more than 10 consumers reported an issue with the product. “The fact is the USDA inspects every finished food lot and approves it ...
Gizmodo15d
New Antibiotic Hits the Market to Tackle Stubborn UTIs
This month, the Food and Drug Administration approved Iterum Therapeutics’ Orlynvah for certain kinds of urinary tract infections that aren’t likely to respond to other drugs. UTIs are some of ...
The Conversation15d
Alzheimer’s drug approved in the UK, but it won’t be available on the NHS – here’s why
Rahul Sidhu does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond ...
copdnewstoday16d
FDA approves first RSV vaccine for at-risk adults younger than 50
The U.S. Food and Drug Administration (FDA) has approved Abrysvo, a vaccine that protects against lung infections caused by the respiratory syncytial virus — commonly known as RSV — for adults as ...