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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...
We can't buy the best sunscreen in the U.S. Here's why
The Desert Sun via Yahoo News· 2 hours ago“We have asked the FDA to consider allowing market access.” The FDA is hamstrung by a 1938 law that...
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 grants breakthrough therapy status for Nuvalent’s NVL-655
Pharmaceutical Technology via Yahoo Finance· 8 hours agoThe US Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) for...
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...
R3 Vascular raises $87M to test its bioresorbable scaffold for blocked arteries below the knee
FierceBiotech· 2 hours agoOn the heels of a groundbreaking FDA approval for a major medtech, a Silicon Valley startup is...
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.
EPA, FDA, and USDA Issue Joint Regulatory Plan for Biotechnology | JD Supra
JD Supra· 11 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 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...
Mizuho raises Sarepta Therapeutics stock target on FDA hopes By Investing.com
Investing.com· 6 hours agoThis adjustment comes after a discussion with a former FDA regulatory clinical expert, which...