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R3 Vascular raises $87M to test its bioresorbable scaffold for blocked arteries below the knee
FierceBiotech· 46 minutes agoOn the heels of a groundbreaking FDA approval for a major medtech, a Silicon Valley startup is...
FDA-Approved HPV Self-Screening Tests Aim to Improve Cervical Cancer Prevention
Verywell Health via Yahoo News· 34 minutes agoLalocracio / Getty Images Fact checked by Nick Blackmer Key Takeaways The FDA has approved a new...
Analysts weigh in on FDA's approval for Amgen's small cell cancer drug By Investing.com
Investing.com· 3 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· 4 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· 12 hours agoAs the FDA's use of surrogate endpoints in the drug approval process is increasing, researchers are...
FDA issues import alerts against 2 more plastic syringe manufacturers
MedTech Dive via Yahoo Finance· 7 hours agoThe FDA has asked healthcare providers to immediately transition away from using plastic syringes...
FDA approves Amgen drug for tough-to-treat form of lung cancer
BioPharma Dive via Yahoo Finance· 5 hours agoImdelltra, a bispecific antibody targeting a protein called DLL3, is cleared for use following...
FDA grants breakthrough therapy status for Nuvalent’s NVL-655
Pharmaceutical Technology via Yahoo Finance· 7 hours agoThe US Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) for...
FDA Approves New Drug for Deadly Lung Cancer
Alaska Superstation· 5 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...