Perimeter Files FDA PMA Application for its Next-Generation B-Series OCT with ImgAssist AI 2.0
Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTCQX: PYNKF) ("Perimeter" or the "Company"), a commercial-stage medical technology company, today announced the submission of a Premarket Approval ...
FDA Approves New Prostate Cancer Imaging Agent Gozellix®
Gozellix®, after radiolabeling with 68 Ga, is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive ...
News Medical5d
Scientist whose work led FDA to ban food dye says agency overstated risk
When the FDA announced in January, before President Joe Biden's term ended, that it would ban a dye called red dye No. 3 in food and ingested drugs, the federal agency cited just one 1987 study on ...
FDA Clears Magstim Transcranial Magnetic Stimulation System for U.S. Adolescent Patient Treatment
This FDA clearance for the Magstim Horizon 3.0 and Inspire systems builds on the existing patient TMS clearances for adult patients, making it possible for physicians and nurse practitioners to treat ...
Food Safety News3d
A practical guide to building a food safety culture for retail settings
By Laura M. Wildey Kearse The phrase "food safety culture" is everywhere these days, but what does it mean and how can you, a ...
Scientist whose work led FDA to ban food dye says agency overstated risk
When the FDA announced in January, before President Joe Biden's term ended, that it would ban a dye called red dye No. 3 in ...
Rhythm Pharmaceuticals Reacquires Licensing Rights to IMCIVREE® (setmelanotide) in China with Termination of Agreement with RareStone Ltd.
Under the agreement, Rhythm has agreed to repay $6.3 million in cash to RareStone. Rhythm also agreed to return all shares of RareStone that were acquired under the original agreement for no ...
Second Data Safety Monitoring Board Issues Positive Recommendation to Continue BriaCell’s Phase 3 Study in Metastatic Breast Cancer
The Data Safety Monitoring Board (DSMB) identified no safety concerns, and recommended continuation of BriaCell’s pivotal Phase 3 study of ...
FDA staff return to crowded offices, broken equipment and missing chairs
WASHINGTON (AP) — Thousands of employees returned to the Food and Drug Administration’s headquarters Monday to find ...
XORTX Announces Update for Discussion with the FDA
Type B Meeting Discussion to Accelerate XRx-026 for Gout to NDA ● CALGARY, Alberta, March 19, 2025 (GLOBE NEWSWIRE) -- XORTX Therapeutics ...
Business Insider5d
vTv Therapeutics says FDA has lifted clinical hold on cadisegliatin program
vTv Therapeutics (VTVT) announced that the United States Food and Drug Administration has lifted the clinical hold on the cadisegliatin clinical program, which includes the CATT1 Phase 3 trial in ...