Abrysvo (respiratory syncytial virus vaccine; Pfizer Inc.) is a vaccine indicated for active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age.
Emerging Technology Reports
The Emerging Technology Report provides regular updates about emerging and potentially disruptive technologies that are likely to have a significant impact in healthcare. This “early warning” report monitors new health technologies from 6 months to 2 years within a regulatory submission and tracks those as they go through clinical trial development and the regulatory approval process.
For each emerging technology, our analysts describe the technology and intended use, its prospects relative to the regulatory process and FDA information, competing technologies, relevant clinical guidelines, high-level look at the evidence such as published abstracts in the medical literature and available meeting abstracts, and available clinical trials.
The Spring Distraction System (Cresco Spine) is an investigational, growth-friendly implant in development for the treatment of early onset scoliosis (EOS). It is designed to provide continuous distraction and avoid the need for repeated lengthening procedures as the patient grows.
Palovarotene (Sohonos; Ipsen Biopharmaceuticals Inc.) is an oral retinoid indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for female persons and 10 years and older for male persons with fibrodysplasia ossificans progressiva.
Atidarsagene autotemcel is an investigational gene therapy administered by intravenous infusion for the treatment of metachromatic leukodystrophy.
Eplontersen is an investigational, injectable, ligand-conjugated antisense drug for treatment of hereditary transthyretin amyloidosis with polyneuropathy.
Hepzato Kit (Melphalan/Hepatic Delivery System; Delcath Systems Inc.) Liver-Directed Therapy for Metastatic Uveal Melanoma
The Melphalan/Hepatic Delivery System (Hepzato Kit; Delcath Systems Inc.) is a melphalan drug pack and catheter-based chemofiltration delivery kit indicated as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymp…
Nirsevimab-alip (Beyfortus; AstraZeneca and Sanofi) to Prevent Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus
Nirsevimab-alip (Beyfortus; AstraZeneca) is a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor indicated for the prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
Avasopasem manganese (Galera Therapeutics Inc.) is an investigational intravenous superoxide dismutase mimetic intended to reduce the incidence and severity of radiation-induced oral mucositis in patients undergoing radiotherapy for head and neck cancer.
Bulevirtide (Gilead Sciences Inc.) is an investigational, first-in-class, subcutaneously injected virion entry inhibitor proposed for the treatment of chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease.
Humacyl (Humacyte Inc.) is a bioengineered human acellular vessel proposed for use as a conduit for hemodialysis in patients with end stage renal disease.