JD Supra3h
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 ...
clinicalpainadvisor.com12h
FDA Drug Approval Decisions Expected in March 2025
The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for ...
Does at-home red light therapy really work? Learn the science from our experts
Our experts explain the science behind red light therapy, and if it really works. Plus, we recommend some FDA-cleared wands ...
Hosted on MSN1d
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 ...
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 Announces FDA has Granted Breakthrough Device Designation for ACR-368 OncoSignature Assay for Endometrial Cancer
The ACR-368-tailored OncoSignature assay is being used to predict patients most likely to respond to ACR-368 in Acrivon’s ongoing, ...
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 ...
Business Wire3d
FDA Approves Genentech’s Susvimo as the First and Only Continuous Delivery Treatment for the Leading Cause of Diabetes-Related Blindness
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug ...
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 ...
JD Supra4d
How New Executive Orders May Affect FDA’s Medical Device Operations
Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...
Alpha Tau announces FDA approval of IDE supplement
Medical announced an approval from the U.S. Food and Drug Administration, FDA, of an Investigational Device Exemption IDE, ...