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Analysts weigh in on FDA's approval for Amgen's small cell cancer drug By Investing.com
Investing.com· 17 minutes 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· 1 hour agoThe FDA clearance follows a phase II clinical trial which found the Brainomix 360 e-Lung system...
FDA Approves New Drug for Deadly Lung Cancer
Alaska Superstation· 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...
Critics Say FDA's Use of Surrogate Markers Falling Short
Medscape· 10 hours agoAs the FDA's use of surrogate endpoints in the drug approval process is increasing, researchers are...
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...
No, Tampax Has Not Changed the Size of Their Tampons
People via Yahoo News· 2 hours ago"Tampons are regulated by the U.S. Food and Drug Administration (FDA) and adhere to industry absorbency or size ranges as listed on the side of each...
FDA grants breakthrough therapy status for Nuvalent’s NVL-655
Pharmaceutical Technology via Yahoo Finance· 4 hours agoThe US Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) for...
FDA approves first self-test for cervical cancer
Homenewshere.com· 5 hours agoThe FDA now says self-collected vaginal samples can now be screened at doctor’s office or urgent care facilities.
Mizuho raises Sarepta Therapeutics stock target on FDA hopes By Investing.com
Investing.com· 3 hours agoThis adjustment comes after a discussion with a former FDA regulatory clinical expert, which...
FX Shoulder obtains FDA 510(k) clearance for glenoid baseplates
Medical Device Network via Yahoo Finance· 6 hours agoFX Shoulder Solutions has secured 510(k) clearance from the US Food and Drug Administration (FDA)...