Resources, Guidelines, and Guidance Documents

Martin A. Makary, confirmed by a bipartisan vote of the US Senate, has been sworn in as FDA’s new commissioner.

Marks called out an ‘assault’ on truth and science in his resignation letter, which has sent the bio/pharmaceutical industry reeling.

Sherwin-Williams will showcase its advanced coating systems, which are designed to ensure safety, sterility, and efficiency in pharmaceutical manufacturing environments.

In response to a presidential Executive Order, the Department of Health and Human Services is planning to reduce its workforce, including cutting FDA staff by 3500 full-time employees, and reorganize some key departments.

The commission’s approval makes durvalumab the first and only immunotherapy for LS-SCLC in the EU.

The Therapeutic Goods Administration (TGA) of Australia confirmed its initial decision to decline approval of the mAb for treating early Alzheimer’s disease.