US FDA approves injectable form of Bristol Myers' Opdivo
The U.S. Food and Drug Administration said on Friday that it has approved an injectable version of Bristol Myers Squibb's ...
JD Supra1d
FDA’s Fresh Take on Use of “Healthy” in Food Labeling
On December 19, 2024, the US Food and Drug Administration (FDA) issued a new final rule titled “Food Labeling: Nutrient Content Claims; Definition ...
FiercePharma3d
FDA warning letter reveals quality control, data integrity issues at Viatris plant in India
In a warning letter posted online late last month, the FDA scolded Viatris over a range of production slights at the ...
BioPharma Dive3d
5 FDA decisions to watch in the first quarter of 2025
By the end of March, the regulator could clear a highly anticipated pain drug from Vertex and a heart drug that’s critical to Alnylam’s future.
Integra LifeSciences reports FDA warning letter related to quality system issues
In a regulatory filing on Monday, Integra LifeSciences (IART) said that on December 19, 2024, a subsidiary received a warning letter from the ...
MassDevice3d
Integra Lifesciences receives FDA warning letter for quality systems issues at three locations
Integra Lifesciences recently received an FDA warning letter pertaining to quality systems issues at several facilities.
FDA Accepts Final Protocol for Pivotal Phase 3 Alzheimer’s Disease Study, Streamlining Development Pathway
MALVERN, Pa., Jan. 07, 2025 (GLOBE NEWSWIRE) -- via IBN – Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a late-stage ...
FDA approves injectable version of Bristol Myers Squibb's cancer drug Opdivo
The U.S. Food and Drug Administration said on Friday that it has approved an injectable version of Bristol Myers Squibb's ...
Food Safety News2d
FDA makes changes in food contact and lead in baby food as new year begins
The Food and Drug Administration will change its food safety policy as 2025 progresses.  Monday’s latest is the FDA issued a notice in the Federal ...
FDA approves injectable version of Bristol Myers Squibb's cancer drug Opdivo (Dec. 27)
The U.S. Food and Drug Administration said on Friday that it has approved an injectable version of Bristol Myers Squibb's ...
MassDevice2d
Alleviant Medical wins FDA IDE, breakthrough nods for no-implant heart failure treatment
Alleviant Medical announced that it received FDA investigational device exemption and breakthrough device designation for its ...
WTAE-TV13d
FDA proposes new testing rules to ensure cosmetics are asbestos-free
But recent FDA-sponsored testing hasn't uncovered any safety issues ... especially in cases of ovarian cancer, which is a ...