FDA Roundup: June 6, 2023

SILVER SPRING, Md., June 6, 2023 /PRNewswire/ — Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Monday, the FDA issued a Letter to Health Care Providers recommending health care facilities and health care providers implement conservation strategies for non-sterile, single-use pneumatic tourniquet cuffs in … Read more

Sun Life U.S. offers new dental plan options to help members reduce out-of-pocket costs and maintain preventive care

WELLESLEY, Mass., June 6, 2023 /PRNewswire/ — As part of its Lifetime of Smiles® oral health platform, Sun Life U.S. has launched two new PPO dental plan options for employer clients, to help their employees stretch their benefit dollars and get more coverage for the dental care they need. The Preventive Rewards option incentivizes people to … Read more

The Inner Circle Acknowledges, Deniz Baysal, MD, FRCSC as a Distinguished Medical Professional for his contributions to the Orthopedic Field

FRESNO, Calif., June 6, 2023 /PRNewswire/ — Prominently featured in The Inner Circle, Deniz Baysal is acknowledged as a Distinguished Medical Professional for his contributions to the Orthopedic Field. Deniz Baysal, MD, FRCSC Dr. Baysal began his academic journey at the University of Calgary where he earned a Bachelor of Science degree in Biology. He … Read more

Janssen Submits Supplemental Biologics License Application to U.S. FDA Seeking Approval of CARVYKTI® for the Earlier Treatment of Patients with Relapsed or Refractory Multiple Myeloma

Application is supported by data from the Phase 3 CARTITUDE-4 study, which showed significant improvement in primary endpoint of progression-free survival (PFS) CARTITUDE-4 is the first randomized Phase 3 study investigating the efficacy of a cell therapy as early as after first relapse in multiple myeloma RARITAN, N.J., June 6, 2023 /PRNewswire/ — The Janssen Pharmaceutical … Read more

Ionis announces proposed private placement of convertible notes

CARLSBAD, Calif., June 6, 2023 /PRNewswire/ — Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced today that it intends to offer, subject to market conditions and other factors, $500.0 million aggregate principal amount of Convertible Senior Notes due 2028 (the “notes”) in a private placement (the “offering”) to qualified institutional buyers pursuant to Rule 144A under the … Read more

U.S. Department of Justice Awards ICF $22 Million Technical Assistance Contract

Work Will Strengthen Capacity of Victim Service Organizations RESTON, Va., June 6, 2023 /PRNewswire/ — ICF (NASDAQ:ICFI), a global consulting and technology services provider, was recently awarded a contract by the U.S. Department of Justice Office for Victims of Crime (OVC) to provide training and technical assistance (TTA) to better support and serve victims and … Read more

Ceek Women’s Health Introduces the Nella Single-Use Vaginal Speculum with Integrated Sidewall Retractors and LED Light

The First Modern Disposable Speculum with Superior Benefits for Clinicians and a Comfortable Design for Patients PORTLAND, Ore., June 6, 2023 /PRNewswire/ — Ceek Women’s Health, an award-winning medical device company, is proud to introduce the Nella Single-Use Vaginal Speculum with Integrated Sidewall Retractors and LED Light. This innovative speculum was designed by women for … Read more

FDA Permits Marketing of First COVID-19 At-Home Test Using Traditional Premarket Review Process

SILVER SPRING, Md., June 6, 2023 /PRNewswire/ — Today, the U.S. Food and Drug Administration granted marketing authorization for the Cue COVID-19 Molecular Test. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in nasal swabs from adults with signs and symptoms of … Read more

iHerb nawiązuje partnerstwo z CJ Logistics, aby zwiększyć dostępność produktów z kategorii zdrowie i wellness na Bliskim Wschodzie i w Afryce

Firma iHerb zorganizowała wspólną ceremonię w Rijadzie, aby ogłosić partnerstwo na rzecz budowy pierwszego centrum obsługi zamówień internetowych w Arabii Saudyjskiej IRVINE, Kalifornia, 6 czerwca 2023 r. /PRNewswire/ — iHerb, globalny lider w dziedzinie zdrowia i wellness, ma zaszczyt ogłosić nawiązanie partnerstwa z CJ Logistics, liderem rozwiązań logistycznych, aby stworzyć pierwsze centrum e-handlu w Arabii … Read more

GIE Medical Granted FDA’s Breakthrough Device Designation for Multi-Stage Drug Coated Balloon to Treat Esophageal Strictures

Designation may provide U.S. patients faster access to groundbreaking technology PLYMOUTH, Minn., June 6, 2023 /PRNewswire/ — GIE Medical, a clinical stage company developing solutions for patients suffering from benign stricture(s) of the esophagus or bowel, was granted designation as a Breakthrough Device from the U.S. Food and Drug Administration (FDA) for its ProTractX3™ TTS … Read more