Japanese partner Kissei Pharmaceutical Co., Ltd. said it has started information-sharing activities in Japan, urging ...
FDA clinical hold on ARD-101, cash-backed valuation, and key catalysts ahead. Click for more on recent developments with AARD ...
As healthcare AI adoption accelerates, HAIOps is emerging as a critical framework for governance, compliance, safety, ...
The FDA approved a peptide for a rare mitochondrial disease. But what's more interesting is the more common potential use ...
Compliance Ready Software brings technical controls that comply with 21 CFR Part 11 to the Opentrons Flex. The new offering gives regulated labs an audit-ready automation option with a faster path ...
The US Food and Drug Administration (FDA) has issued warning letters to two researchers for failing to meet good clinical practice (GCP) requirements and for not complying with their own trial ...
The warning letter, issued on March 30 following a September 2025 inspection, says the company’s manufacturing practices have failed to comply with good manufacturing norms ...
The FDA has moved to pull Tavneos (avacopan) from the U.S. market, alleging that manipulated clinical trial data propped up the drug’s 2021 approval for a rare and potentially fatal blood vessel ...
When hospitals overcharge insurers for drugs they bought at deep 340B discounts, taxpayers, employers, and insured patients ...
Synopsis: As global markets prioritise quality and regulatory trust, India’s pharma sector is recalibrating beyond its traditional cost advantage.
The administration has also been making its own moves, on Wednesday, announcing its own coalition of organizations spanning ...
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