Search results
Analysts weigh in on FDA's approval for Amgen's small cell cancer drug By Investing.com
Investing.com· 2 hours agoThe U.S. Food and Drug Administration (FDA) on Thursday granted accelerated approval to Amgen's...
Brainomix swings FDA clearance for its lung imaging AI software
Medical Device Network via Yahoo Finance· 3 hours agoThe FDA clearance follows a phase II clinical trial which found the Brainomix 360 e-Lung system...
FDA approves self-collection screening tests for HPV, allowing women to avoid pelvic exams for...
FierceBiotech· 2 days agoThe FDA has approved two diagnostic devices that allow women to collect vaginal samples themselves...
Critics Say FDA's Use of Surrogate Markers Falling Short
Medscape· 11 hours agoAs the FDA's use of surrogate endpoints in the drug approval process is increasing, researchers are...
EPA, FDA, and USDA Issue Joint Regulatory Plan for Biotechnology | JD Supra
JD Supra· 9 hours agoOn May 8, 2024, the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) released a plan to update ...
FDA grants breakthrough therapy status for Nuvalent’s NVL-655
Pharmaceutical Technology via Yahoo Finance· 6 hours agoThe US Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) for...
FDA approves new drug for deadly lung cancer
Medical Xpress· 3 hours agoImportantly, tarlatamab (Imdelltra) is only for patients who have exhausted all other options to treat extensive-stage small cell lung cancer. "The FDA's...
FDA issues import alerts against 2 more plastic syringe manufacturers
MedTech Dive via Yahoo Finance· 6 hours agoThe FDA has asked healthcare providers to immediately transition away from using plastic syringes...
FDA approves first self-test collection kit for HPV
Medical Xpress· 1 day agoMore than half of U.S. women diagnosed with cervical cancer have never been screened or screened only infrequently for the virus, the kit's maker Roche...
FX Shoulder obtains FDA 510(k) clearance for glenoid baseplates
Medical Device Network via Yahoo Finance· 7 hours agoFX Shoulder Solutions has secured 510(k) clearance from the US Food and Drug Administration (FDA)...
