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 ...
Tonix Pharmaceuticals Reports Third Quarter 2024 Financial Results and Operational Highlights
Submitted New Drug Application (NDA) to FDA for TNX-102 SL for fibromyalgia based on two statistically significant Phase 3 studiesGranted Fast ...
MassDevice9h
FDA clears AI-powered breast cancer detection tech from iCad
Cad (Nasdaq:ICAD) announced today that the FDA cleared its ProFound Detection version 4.0 for digital breast tomosynthesis ...
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 ...
FiercePharma1d
Autolus readies its CAR-T Aucatzyl to go after heavy hitter competition following FDA nod
Watch out, Gilead and Novartis: there's a new CAR-T in town. Autolus is ready to hit the ground running after winning FDA approval for its Aucatzyl, a late entry to the heated CD19 CAR-T cell therapy ...
From AI to Musk’s brain chips, the FDA’s device unit faces rapid change
The new director at the FDA overseeing medical devices will confront criticisms about hasty approvals as she ushers in ...
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 ...