FDA Grants Breakthrough Therapy Designation to VERTANICAL's VER-01, a First-in-Class Non-Opioid Investigational Treatment for Chronic Low Back Pain

VERTANICAL today announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to VER-01, the company's first-in-class non-opioid investigational treatment for ...
Pharmaceutical Technology on MSN

Vertanical’s VER-01 gains FDA breakthrough status for low back pain

VER-01 offers an investigational approach distinct from traditional treatment paradigms.
Monthly Prescribing Reference

Survodutide Designated Breakthrough Therapy for MASH

Phase 2 trial results showed an improvement in MASH with no worsening of fibrosis in all treatment groups compared with placebo. The Food and Drug Administration (FDA) has granted Breakthrough Therapy ...

Breakthrough Targeted Therapy Shows Promise for KRAS‑Mutated Pancreatic Cancer, with Virginia Cancer Specialists and NEXT Oncology Playing Key Role

Virginia Cancer Specialists announced today its participation as a leading clinical trial site in a landmark study evaluating daraxonrasib, a first‑in‑class targeted oral therapy for patients with ...
Monthly Prescribing Reference

Nipocalimab Designated Breakthrough Therapy for Sjögren Disease

Nipocalimab 15mg/kg improved ClinESSDAI score compared with placebo (treatment difference -2.65; [90% CI, -4.03, -1.28]; P =.002). The Food and Drug Administration (FDA) has granted Breakthrough ...

Scientists Turn Cancer’s Own Bacteria Against It in Breakthrough Therapy

A newly developed therapy inspired by bacteria residing within tumors offers a different way to combat cancer by targeting ...
Yahoo

Breakthrough gene therapy jab reverses hearing loss in weeks

A single jab of a breakthrough gene therapy could reverse hearing loss in people within weeks, according to new research. The cutting-edge therapy improved hearing in children and adults with ...
Nasdaq

Orchestra BioMed Receives FDA Breakthrough Device Designation for Atrioventricular Interval Modulation Therapy to Address Uncontrolled Hypertension

Orchestra BioMed has announced that the FDA has granted Breakthrough Device Designation for its atrioventricular interval modulation (AVIM) therapy, aimed at treating over 7.7 million U.S. patients ...
Nasdaq

FDA Grants Breakthrough Therapy Status To Cidara's CD388 For Prevention Of Influenza A And B

(RTTNews) - Cidara Therapeutics, Inc. (CDTX) on Thursday said that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for CD388 for prevention of influenza A and ...

Jaguar Health Announces Preliminary Discussion with FDA to Evaluate Breakthrough Therapy Designation for Crofelemer for Treatment of Microvillus Inclusion Disease (MVID)

Pediatric patients with Intestinal Failure (IF) due to MVID, an ultrarare congenital disorder with lethal natural ...
Healio

Prosthetic joint infection therapy gets breakthrough designation from FDA

Please provide your email address to receive an email when new articles are posted on . The FDA granted Osteal’s VT-X7 breakthrough therapy designation based on recent trial data. The investigational ...
Psychology Today

breakthrough therapy and resources

At Breakthrough Therapy and Resources, we provide clinical support for individuals experiencing distress due to various life experiences. Utilizing a range of therapeutic interventions, we offer ...