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Empower Pharmacy, a Houston-based compounding pharmacy, has been sanctioned by the FDA and other states in the past decade.
In this video interview, Luke Wilson, senior director, biotech, pharma services at Thermo Fisher Scientific, discusses how ...
Research Triangle Park, NC site received a positive FDA Review, marking a milestone as all company Analytical Outsourcing ...
Moon N Sea Ga Llc. issued a voluntary recall on June 24 for various fish products after they were potentially produced under ...
A year ago, applications for a cell-cultured foie gras product were dropped off at the United States Food and Drug ...
Research Triangle Park, NC site received a positive FDA Review, marking a milestone as all company Analytical Outsourcing sites have achieved successful recent inspections MINNEAPOLIS, MINNESOTA / ACC ...
Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.
Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and ...
The CEO said that the FDA's regulation of sunscreen, particularly for organic products, was "impossible" to meet.
Protein-based biotherapeutics are drugs made with genetically engineered proteins. These large protein molecules can stick ...
FDA response expected within six weeks; Company remains focused on 2025 U.S. expansionNEW YORK, Aug. 06, 2025 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company" ...
Until the FDA streamlines and modernizes its regulatory process, states will continue stepping in, with inconsistent and ...