Vigil Neuroscience study for Alzheimer’s drug to proceed with FDA restrictions (VIGL)
Iryna Drozd Vigil Neuroscience (NASDAQ:VIGL) said the FDA is allowing a Phase 1 clinical trial for its Alzheimer’s drug candidate ...
Monday, May 12, 2025
Tag: FDA
US FDA issues warning letters to three baby formula manufacturers By Reuters
© Reuters. FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, ...
Regeneron high-dose Eylea gains FDA approval (NASDAQ:REGN)
Iryna Drozd The US FDA has approved Regeneron Pharmaceuticals' (NASDAQ:REGN) high-dose ("HD") version of its blockbuster therapy Eylea (aflibercept). The ...
US FDA approves Biogen-Sage Therapeutics pill for postpartum depression By Reuters
© Reuters (Reuters) -The U.S. Food and Drug Administration (FDA) on Friday approved Biogen (NASDAQ:) and Sage Therapeutics' oral pill ...
Mesoblast shares tank after US FDA rejects cell therapy for children By Reuters
© Reuters. FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, ...
First over-the-counter birth control pill gets FDA approval in U.S.
U.S. officials have approved the first over-the-counter birth control pill, which will let American women and girls buy contraceptive medication ...
US FDA declines to approve Regeneron’s higher-dose Eylea, shares tumble By Reuters
© Reuters. FILE PHOTO: The Regeneron Pharmaceuticals company logo is seen on a building at the company's Westchester campus in ...
Intercept stock falls after FDA AdCom snub for NASH therapy
Sena Yiğiter Intercept Pharmaceuticals (NASDAQ:ICPT) fell ~28% on Monday as its shares resumed trading after a group of independent experts ...
FDA advisers back RSV vaccine for pregnant women
Women would receive a single injection late in pregnancy, between 24 weeks and 36 weeks, so they develop RSV-fighting antibodies ...
Second Omicron booster approved for seniors by FDA
US regulators authorized a second round of omicron-targeted boosters for individuals older than 65 and those with weakened immune systems. ...
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