The multi-center PROACTIVE-HF trial of the Cordella Pulmonary Artery (PA) Pressure Sensor System (Cordella Sensor) has been approved by the Food and Drug Administration (FDA). The point of the trial is to expedite pre-market approval (PMA) of the Cordella Sensor and provide evidence to the Centers for Medicare & Medicaid Services (CMS).
binx io enables first-ever "test-and-treat" paradigm with sample to answer in 30 minutes for the two most tested-for sexually transmitted infections (STIs)
Approval marks the second drug approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs and signals FDA’s continued focus on facilitating development of new treatments to fight antimicrobial resistant infections
The U.S. Food and Drug Administration periodically provides information on the pace of generic drug approvals through its website.
FDA also approves drug for second indication in a type of lung cancer
The pharmaceutical industry is looking at artificial intelligence (AI) to have a major impact on the future of medicine as relationships between pharma corporations and AI researchers are already flourishing in the hopes of one day providing a faster and more reliable digital health care service to patients around the nation.
The Tobacco and Nicotine Products Regulation and Policy Conference will take place Oct. 24-25.
The Food and Drug Administration Office of Prescription Drug Promotion recently sent a letter to Aclaris due to false or misleading claims for its direct-to-consumer advertising for Eskata.
Founder Dale Taylor Will Remain CEO and Chairman of the Board
Today, the U.S. Food and Drug Administration approved Inrebic (fedratinib) capsules to treat adult patients with certain types of myelofibrosis.
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The U.S. Food and Drug Administration today approved the first spinal tether device intended to be used in children and adolescents to correct the most common form of scoliosis, called idiopathic scoliosis, that has not responded to conservative treatment options, such as external bracing.
The U.S. Food and Drug Administration approved an expanded indication for several transcatheter heart valves to include patients with severe aortic valve stenosis (a narrowing of the heart’s aortic valve that restricts blood flow to aorta, the body’s main artery) who are at low risk for death or major complications associated with open-heart surgery to replace the damaged valves.
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The U.S. Food and Drug Administration approved the Barostim Neo System for the improvement of symptoms in patients with advanced heart failure who are not suited for treatment with other heart failure devices, such as cardiac resynchronization therapy.
BAROSTIM™ NEO provides significant clinical benefit to heart failure patients
The Tether™ represents the first approval order for a humanitarian use device in spinal pediatrics within the last 15 years
INREBIC provides new, once-daily oral option for patients affected by rare bone marrow cancer
Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its investigational Zika vaccine (mRNA-1893) currently being evaluated in a Phase 1 study for the prevention of Zika virus infection in healthy adults.
Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced today that the U.S. Food and Drug Administration (FDA) has approved Nabriva’s new drug applications for the oral and intravenous (IV) formulations of Xenleta™ (lefamulin) for the treatment of community-acquired bacterial pneumonia (CABP) in adults.
The U.S. Food and Drug Administration today approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia.
Cassiopea SpA (SIX: SKIN), a specialty pharmaceutical company developing and commercializing prescription drugs with novel mechanisms of action (MOA) to address long-standing and essential dermatological conditions, announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for clascoterone cream 1% for the treatment of acne.