A rushed HHS performance review process, with capped top ratings and unnamed review boards, is exacerbating morale concerns ...
A proposed CMS and CDC rule would codify remote review of digital lab data, ease 2023 personnel qualification standards and ...
A provision in the forthcoming pharmaceutical reform package aims to improve equality in access to medicines across the EU ...
US FDA India director says that quality should be the “normal state of operation”, rather than a condition created ahead of ...
FDA staff said the move to allow compounding of some unapproved peptide products raises patient safety concerns and weakens ...
Medical Microinstruments raised $125m in Series D funding, led by BioStar Capital. The firm will use the funds to expand ...
The cell therapies in development for autoimmune diseases aren’t seen as curative, but they still have to provide lasting benefit to demonstrate their value.
The Pink Sheet’s Drug Review Profile looks at key milestones in the development, review and approval of the LDL cholesterol-lowering drug enlicitide under the Commissioner’s National Priority Voucher ...
AdvaMed is urging the US Copyright Office not to renew an exemption allowing independent servicers to repair medical devices.
A range of speakers from government, regulators and the industry lay out at the BioJapan meeting in Yokohama the major ...
The German group is hoping to get the green light for the mineralocorticoid receptor antagonist for adults with chronic ...
Leaders in the cell therapy field talked about how to expand access to CAR-T cell therapy, with one exec saying bringing it ...
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