Drinking Water Recall Update as FDA Changes Status
The U.S. Food and Drug Administration (FDA) terminated a recall for Berkeley Club Beverages water on November 13 and recently ...
Benefits Pro5h
Pharmacies lobby FDA for right to keep making weight-loss drugs
Pharmacies that make customized medications are asking the federal Food and Drug Administration to protect their right to ...
GlobalData on MSN8h
FDA approves Syndax’s Revuforj to treat leukaemia
The US Food and Drug Administration (FDA) has approved Syndax Pharmaceuticals' Revuforj (revumenib) for treating relapsed or ...
Dietary Supplement Recall Update As FDA Sets Risk Level
A Vitamin B supplement has been recalled due to being incorrectly formulated with niacin rather than niacinamide.
MassDevice2h
Think Surgical wins another FDA clearance for its surgical robot
Think Surgical announced today that it received FDA 510(k) clearance to use its TMINI surgical robot with the LinkSymphoKnee.
FiercePharma5h
Syndax ⁠scores FDA approval for Revuforj after it disappointed in another acute leukemia indication
The U.S. patient population for Revuforj in its approved indication is roughly 2,000 according to Syndax. KMT2A leukemias ...
Targeted Oncology4h
FDA Clears Spectral 4DCT for Precision in Radiation Oncology
The FDA-cleared Spectral CT 7500 RT, a detector-based computed tomography radiotherapy solution aimed to enhance radiation ...
Rolling Out2d
7 shocking truths about cold medicine that the FDA says doesn’t actually work
The FDA has just dropped a truth bomb: if you’ve been relying on those familiar red pills for a stuffy nose, it might be time ...
MarketWatch35m
Aldeyra Therapeutics Shares Up, FDA to Review New Drug Application
Aldeyra would also be eligible to receive up to $300 million in regulatory and commercial milestone payments, including a $100 million payment due if FDA approval for the treatment is granted. As ...
MassDevice4h
BrightHeart earns FDA clearance for AI-powered prenatal heart ultrasound tech
BrightHeart announced that it received FDA 510(k) clearance for its first AI software for prenatal ultrasound evaluations of ...
Business Insider15h
Autolus Therapeutics: FDA Approval of Aucatzyl De-Risks Platform, Significant Upside Anticipated
The recent approval of their lead asset, Aucatzyl, by the FDA is seen as a pivotal factor in de-risking the company’s technology platform and manufacturing capabilities. The differentiated safety ...