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Critics Say FDA's Use of Surrogate Markers Falling Short
Medscape· 13 hours agoAs the FDA's use of surrogate endpoints in the drug approval process is increasing, researchers are...
R3 Vascular raises $87M to test its bioresorbable scaffold for blocked arteries below the knee
FierceBiotech· 1 hour agoOn the heels of a groundbreaking FDA approval for a major medtech, a Silicon Valley startup is...
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 Amgen drug for tough-to-treat form of lung cancer
BioPharma Dive via Yahoo Finance· 6 hours agoImdelltra, a bispecific antibody targeting a protein called DLL3, is cleared for use following...
FDA issues import alerts against 2 more plastic syringe manufacturers
MedTech Dive via Yahoo Finance· 8 hours agoThe FDA has asked healthcare providers to immediately transition away from using plastic syringes...
FDA Approves New Drug for Deadly Lung Cancer
Alaska Superstation· 6 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 approves first self-test for cervical cancer
Homenewshere.com· 8 hours agoThe FDA now says self-collected vaginal samples can now be screened at doctor’s office or urgent care facilities.
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...
FDA approves new drug for deadly lung cancer
Medical Xpress· 4 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...
Amgen’s IMDELLTRA receives FDA approval for lung cancer treatment
Pharmaceutical Technology via Yahoo Finance· 9 hours agoAmgen has announced the US Food and Drug Administration's (FDA) accelerated approval for its...