Latest News

IPSEN: Announces FDA Approval of Dysport® (abobotulinumtoxinA) for the Treatment of Upper Limb Spasticity in Children, Excluding Cerebral Palsy

Dysport is the first and only FDA-approved botulinum toxin for treatment of both pediatric upper and lower limb spasticity

SIEMENS HEALTHINEERS: FDA Clears Modules of AI-Rad Companion Chest CT From Siemens Healthineers

AI-based software enables automated enhanced visualization of CT images of the lungs, heart, and aorta

CARDIOVASCULAR SYSTEMS, INC.: Announces FDA Approval of the Coronary ViperWire Advance® With Flex Tip

U.S. Approval of the First and Only Nitinol Atherectomy Guide Wire Expands Company’s Portfolio of Products Targeting Complex Coronary Disease

WEST CANCER CENTER: The first center in the country to offer the first FDA-approved Mesothelioma treatment in more than 15 years

A clinical study showed that the NovoTTF-100L™ System in combination with chemotherapy may help people with malignant pleural mesothelioma extend their lives

EXACT SCIENCES: Cologuard® Gains FDA Approval For Use In Younger Americans, Ages 45 To 49

Stool DNA test offers a sensitive, noninvasive, at-home option to screen for colorectal cancer, second deadliest cancer in U.S.

SANDOZ INC.: Issues Voluntary Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA), in the Product

Sandoz Inc. is voluntarily recalling all quantities and lots within expiry of Ranitidine Hydrochloride Capsules in the US to the consumer level because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA in batches of Sandoz Ranitidine Hydrochloride Capsules.

EMMAUS LIFE SCIENCES: Reinforces Positive Outcomes of Endari ® Clinical Trials, Including Efficacy Findings That Led to FDA Approval

Emmaus Life Sciences, Inc. (OTC: EMMA), a leader in sickle cell disease (SCD) treatment, today released the following summary review of the clinical trials and efficacy findings for Endari®.

INSULET CORPORATION: Insulet’s Omnipod DASH™ System Now FDA Cleared as an Alternate Controller Enabled (ACE) Infusion Pump

Insulet Corporation (NASDAQ: PODD) (Insulet), the global leader in tubeless insulin pump technology with its Omnipod® Insulin Management System, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for an Alternate Controller Enabled Infusion Pump (ACE Pump).

U.S. FDA: Statement from Acting FDA Commissioner Ned Sharpless, M.D., on continued efforts to increase availability of all forms of naloxone to help reduce opioid overdose deaths

Addressing opioid overdose continues to be one of the most urgent public health priorities for the U.S. government and making potentially lifesaving treatments more readily available is one of the top ways we can address this crisis

NOVO NORDISK: FDA approves Rybelsus® (semaglutide), the first GLP-1 analog treatment available in a pill for adults with type 2 diabetes

Rybelsus® represents an innovation in diabetes treatment by providing a GLP-1 receptor agonist in an oral formulation

U.S. FDA: Continues to take steps to fulfill its commitment to strengthen and modernize the 510(k) medical device program

FDA publishes draft guidance documents to provide device-specific performance criteria for the Safety and Performance Based Pathway

AVITA MEDICAL: Receives U.S. FDA Investigational Device Exemption Approval of Pivotal Study Evaluating RECELL System for Soft Tissue Reconstruction

First RECELL System clinical trial in the U.S. focused on acute soft tissue injuries, defects, and reconstruction; study expected to commence within next 6 months

AETION: Former FDA Commissioner Scott Gottlieb Joins Aetion's Board of Directors

Gottlieb joins as Aetion advances real-world evidence for making drug development and commercialization more efficient

MEDICURE INC.: Announces Launch of New and Improved ReDS™ PRO

Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF), a cardiovascular pharmaceutical company, is pleased to announce the launch of the ReDSTM PRO ("ReDSTM PRO") system, the next generation of lung fluid management technology for heart failure.

U.S. FDA: FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma

The U.S. Food and Drug Administration is announcing Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners.

ZIMMER BIOMET: Receives FDA Clearance of JuggerStitch™ Meniscal Repair Device

Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, has announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the JuggerStitch™ meniscal repair device.

SOFWAVE MEDICAL LTD: SofWave Medical's Low-divergence Ultrasound Technology Has Received FDA Clearance for the Aesthetic Treatment of Facial Lines and Wrinkles

Sofwave Medical Ltd., an emerging aesthetic device company, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Sofwave system. The Sofwave device is indicated for use as a non-invasive aesthetic treatment to improve facial lines and wrinkles.

FDA Reporter