A 2026 informational report on the Herz P1 Smart Oximeter fingertip pulse oxygen monitor, covering the company's FDA 510(k) cleared positioning, ±2% SpO2 blood oxygen accuracy specifications, smart ...
The FDA recalled multiple cough drops in 2026 over quality concerns. Learn which products are affected, why they were ...
FDA required additional post-approval evaluation of myocardial infarction, stroke, and other cardiovascular events because ...
Molluscum contagiosum, a common and highly contagious skin infection caused by a poxvirus, affects millions of individuals ...
Generic dapagliflozin is now approved for adults with type 2 diabetes, though current labeling excludes chronic kidney disease and pediatric use.
The FDA approved Radiesse for the treatment of wrinkles in the décolleté area for patients aged 22 years and older, despite ...
The US Food and Drug Administration (FDA) is reviewing a petition to revoke the approval of ocrelizumab for the treatment of ...
Denali Therapeutics (DNLI) added ~9% in the premarket on Wednesday after the U.S. Food and Drug Administration (FDA) approved its lead candidate, tividenofusp alfa, as a treatment for Hunter syndrome, ...
Learn why rapid weight loss may trigger hair loss with Ozempic and discover ways to minimize shedding and regrow your hair.
The FDA has approved Denali Therapeutics’ enzyme replacement therapy for a genetic lysosomal storage disease after a string of high-profile rejections for rare disease candidates. In approving ...
The FDA has delayed its target decision date for Orca Bio’s blood cancer cell therapy candidate Orca-T by three months to July 6. The review extension comes after the company submitted additional data ...
Andrew Joseph covers health, medicine, and the biopharma industry in Europe. You can reach Andrew on Signal at drewqjoseph.71. Jason Mast is a general assignment reporter at STAT focused on the ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results