Drinking Water Recall Update as FDA Changes Status
One drinking water recall issued earlier this year by the U.S. Food and Drug Administration was terminated last week.
Zacks.com on MSN1h
FDA Accepts SNY and REGN's Dupixent Re-Submitted sBLA for Urticaria
The FDA is set to give its decision on SNY and REGN's sBLA for Dupixent for chronic spontaneous urticaria on April 18, 2025.
Benefits Pro7h
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 ...
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.
FiercePharma7h
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 ...
MassDevice4h
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.
GlobalData on MSN10h
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 ...
Targeted Oncology6h
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 ...
BioPharma Dive5h
Syndax secures FDA OK for new kind of leukemia drug
Revuforj is the first so-called menin inhibitor cleared in the U.S., securing FDA approval for use in adults and certain ...
MassDevice6h
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 Insider17h
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 ...