The U.S. Food and Drug Administration (FDA) granted 510(k) clearance for Respinova to market their device that clears secretions for patients with respiratory issues by facilitating the opening of airways. The device, called Pulsehaler, is the first to use patented...
The European Commission has granted Orphan Designation for PBKR03, a treatment from Passage Bio to treat Krabbe disease. Krabbe disease is a rare lysosomal storage disorder that currently does not have any approved disease-modifying treatments. The approval comes...
The European Commission released a roadmap for its planned revision of pharmaceutical legislation for next year. With the adoption of the new strategy, which is “intended to make the European pharmaceutical system patient-centered, future-proof and...
Latin America (LATAM) is a diverse region, with over 650 million people spread across 20 different countries, each with their own culture and unique history. For medical device companies, LATAM is a promising market, with its current value estimated to be $11 billion...
The U.S. Food and Drug Administration (FDA) approved of two treatments to treat high blood pressure (pulmonary hypertension) and cancer (multiple myeloma). United Therapeutics won approval for Tyvaso (treprostinil) Inhalation Solution, its pulmonary hypertension...
The U.S. Food and Drug Administration (FDA) granted Premia Spine’s TOPS™ Spinal Arthroplasty System Breakthrough Device Designation to treat patients diagnosed with spinal stenosis and spondylolisthesis. The approval marks the first ever joint replacement system...
The U.S. Food and Drug Administration (FDA) has issued 22 new and 14 revised product-specific guidances (PSGs) for generic drug development. The guidances provide further clarity to the FDA’s expectations in regards to clinical studies demonstrating...
The U.S. Food and Drug Administration (FDA) approved of the first-ever valve for treating pulmonary valve regurgitation in patients with certain kinds of congenital heart disease. The device, called Harmony Transcatheter Pulmonary Valve (TPV) has been granted...
Takeda’s dengue vaccine candidate’s filing packages has been accepted by the European Medicines Agency (EMA), which is being investigated for its prevention of dengue in individuals between the ages of 4 and 60. Takeda also submitted the vaccine for...
The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) LetsGetChecked’s COVID-19 at-home test to sell directly to consumers at retail stores as well as online. Peter Foley, CEO and Founder of LetsGetChecked stated, “While the...
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