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.
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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.
Gottlieb joins as Aetion advances real-world evidence for making drug development and commercialization more efficient
The most important technology to embrace the beauty industry in the past decade.
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
ResearchAndMarkets.com held a seminar in San Diego on Sept. 12 and 13 entitled, "Managing Your Complaints and Obstacles in Post-Market Requirements – Results from Top Medical Device Observations During an Inspection.”
The U.S. Food and Drug Administration (FDA) removed the alcohol contraindication from Addyi, the only FDA-approved treatment for pre-menopausal women for Hypoactive Sexual Desire Disorder (HSDD).
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The Trump administration’s move to ban certain flavors of e-cigarettes and vaping devices either goes too far or doesn’t go far enough, according to those on opposite sides of the debate.
FDA publishes draft guidance documents to provide device-specific performance criteria for the Safety and Performance Based Pathway
The U.S. Food and Drug Administration barred 485 shipments from entering the United States in August, according to FDA import records.
Rybelsus® represents an innovation in diabetes treatment by providing a GLP-1 receptor agonist in an oral formulation
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
The Prescription Drug Pricing Reduction Act (PDPRA) is expected to work its way through Congress this fall.
Annexon plans to advance the clinical development of ANX005 for the treatment of GBS
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).
The U.S. Food and Drug Administration (FDA) and the U.S. Center for Disease Control (CDC) are relying on myths to scare people away from vaping, according to Alex Berezow of the American Council on Science and Health (ACSH).
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®.
Draft guidance from the U.S. Food and Drug Administration (FDA) on real-world data (RWD) and real-world evidence (RWE) was released in May to mixed reaction from stakeholders.
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.
Stool DNA test offers a sensitive, noninvasive, at-home option to screen for colorectal cancer, second deadliest cancer in U.S.