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May 02, 2023
A strategy on cyber resilience for health and social care organizations has been set out by the UK government.
April 28, 2023
The event, cosponsored by FDA and USP, hosted regulators and industry leaders to discuss the challenges in strengthening the medical product supply chain.
April 24, 2023
The Supreme Court’s action leaves open the prospect of further rulings that could undermine FDA’s approval process.
April 20, 2023
SAB Biotherapeutics has received both breakthrough and fast track designations from FDA for its lead antibody drug candidate for treating influenza.
April 18, 2023
Jaeger notes that the program is focused on addressing specific scientific questions that will produce immediate impacts on how CDER and FDA make drug approval decisions.
AbbVie’s RINVOQ has received European Commission approval for the treatment of moderately to severely active Crohn’s disease.
Gamida Cell’s therapy is meant to reduce the risk of infection following stem cell transplantation.
April 12, 2023
The decision was issued in a joint statement by the FDA Commissioner and Chief Scientist, and effective on April 11.
April 11, 2023
A document signed by members of more than 400 companies and investment firms decries the decision made by a federal judge concerning mifepristone, a medication used in abortions.
April 10, 2023
Will court challenges to FDA’s oversight authority open the door for multiple lawsuits to block agency decisions on all sides?