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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.
December 14, 2023
RoslinCT will manufacture Vertex Pharmaceuticals’ CRISPR-based gene therapy, Casgevy, recently approved for treating sickle cell disease and β thalassemia.
December 13, 2023
The new advisory committee will provide the agency with technical and scientific advice and recommendations on potential treatments for genetic metabolic diseases.
Sanofi has issued a statement expressing its disappointment with FTC’s decision to block an exclusive licensing agreement with Maze Therapeutics for a rare disease drug candidate.
Regulators in the European Union have published the first version a list of critical medicines in the EU to avoid potential shortages.
December 11, 2023
The product is being voluntarily recalled because of powder leakage due to seal integrity issues.
The agency released two guidance documents on the interim policy on compounding using bulk drug substances for both outsourcing and non-outsourcing facilities.