Topic: Breakthrough Therapy
The minimally invasive Valiant TAAA system aims to serve as a new, off-the-shelf intervention, whereas the current standard of care is bypass surgery.
Concept Medical received an FDA breakthrough designation for its balloon designed to open a collapsed access vessel used during dialysis.
Bio-Techne’s urine test has received a breakthrough device designation from the FDA for ruling out unnecessary tissue biopsies.
The drug-eluting balloon opens up the coronary arteries after they’ve reclogged without using a traditional drug coating.
Tonix Pharmaceuticals has lost a U.S. Army agreement to develop TNX-102 SL in military-related post-traumatic stress disorder.
The breakthrough tag comes as Genfit gears up to start a phase 3 trial in the indication later in the year.
Trevena has lost its breakthrough designation for pain treatment oliceridine, just a few months after the FDA rejected its application for the drug.
The FDA finalized its breakthrough device guidance and pitched a new pathway to reward devices that innovate on safety first.
Heron posted new positive phase 2 results for its long-acting anesthetic, HTX-011, in total knee replacements and breast augmentation surgeries.
Ansun BioPharma raised $85 million in series A financing and plans to use the funds for an upcoming phase 3 trial of its DAS181 antiviral medication.