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December 27, 2023
Andelyn Biosciences has been selected by Ultragenyx to manufacture UX111, that company’s gene therapy for treating Sanfilippo Syndrome.
December 26, 2023
WHO provides a look at the world’s health as the agency turns 75.
December 21, 2023
The final guidance document provides recommendations for designing a new registry or using an existing registry to support decisions regarding safety and effectiveness of a drug.
The agencies published a joint guidance document regarding quality development for breakthrough therapies and PRIME programs.
December 20, 2023
Under a collaboration, Daiichi Sankyo and Depixus will use Depixus’ MAGNA technology to accelerate drug discovery efforts of RNA-targeted therapeutics.
Following the divestiture of its Elusys subsidiary and other non-core assets, NightHawk Biosciences will transform into a pure-play large-molecule CDMO.
December 19, 2023
Bristol Myers Squibb and SystImmune plan to co-develop and co-commercialize lead ADC candidate for cancer treatment in US.
December 18, 2023
The Multi-annual AI Workplan creates a strategy to maximize the benefits and manage the risks of artificial intelligence.
December 15, 2023
The guidance document discusses the impact of clinical pharmacology considerations on peptide drug development.
The US District Court for the District of Massachusetts entered a consent decree of permanent injunction against Pharmasol Corporation for distributing adulterated drugs.