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Supernus wins FDA approval for Parkinson’s pump on fourth try
Supernus Pharmaceuticals has won US approval for its wearable pump Onapgo (apomorphine hydrochloride) to treat symptoms of ...
FDA approves wearable infusion device for advanced Parkinson disease
The U.S. Food and Drug Administration has approved Onapgo (apomorphine hydrochloride) injection as the first and only ...
JD Supra6h
Finally, FDA’s Final Word on Unapproved Use Communications
On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms ...
Medical Device Makers Seek Exemption From Trump Tariffs
Medical device makers including Abbott, Johnson & Johnson and Medtronic want an exemption from Trump tariffs that could hit ...
federalnewsnetwork.com9d
FDA’s accelerated approval pathway has a few potholes
The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.
Los Angeles Business Journal12d
Avita Gets FDA Nod For Device
Valencia-based Avita Medical Inc. has received FDA approval for a version of its second-generation Recell skin cell ...
The American Journal of Managed Care3d
FDA Approves Ranibizumab Implant in Treatment of DME
The ranibizumab injection could be administered in a convenient schedule twice per year for the treatment of diabetic macular ...
The Pharma Letter12h
China deepens comprehensive reform to strengthen drug, medical device regulation
China has issued a guideline on comprehensively deepening the reform of regulation of drugs and medical devices to promote the high-quality development of the pharmaceutical industry, the National ...
Modern Healthcare1d
Tariffs on medical devices will raise costs. Here's what to know
The 10% tariffs on Chinese goods began Tuesday. China reacted with a 15% tariff on coal and liquefied natural gas and a 10% tariff on crude oil, agricultural machinery, large-displacement automobiles ...
Acrivon Therapeutics Gets FDA Breakthrough Device Designation for Cancer Identification
Acrivon Therapeutics said the Food and Drug Administration has granted Breakthrough Device designation for its ACR-368 OncoSignature assay, an immunofluorescence assay for the identification of ...
Stockhead on MSN9d
Health Check: Alterity angles for fast-track FDA approval after positive trial results tackling Parkinson’s-like disorder
The trial’s lead investigator, professor Daniel Claassen from Vanderbilt University Medical Centre ... EBR), which is ...
PathMaker Neurosystems Announces IRB Approval for DoD-funded Clinical Trial of the MyoRegulator Device in ALS
Nader Yaghoubi, M.D., Ph.D., PathMaker’s Co-Founder and CEO, stated, “We are pleased to announce IRB approval for the CALM study, which allows us to commence enrollments shortly. Given the mechanisms ...