AstraZeneca has strengthened its oncology and rare disease portfolios with two buy-outs totaling close to $3.5 billion, the company has reported. Source: Drug Industry Daily

This edition of Quick Notes looks at inhaler price caps, a voluntary product recall, Warning Letter and fed support for right to repair. Source: Drug Industry Daily

Recommendations for drug sponsors to assess the impact of impaired renal function on pharmacokinetics (PK) and/or pharmacodynamics (PD) of an investigational drug, how to determine the recommended dosage, and how…

Lenmeldy (atidarsagene autotemcel) manufacturer Orchard Therapeutics received approval from the FDA as the first gene therapy indicated for the treatment of children with pre-symptomatic late infantile/early juvenile or early symptomatic…

Within the supply chain universe, medical technology and its countless components needs to stay front and center when competing with other industries, emphasized the FDA’s lead officer on the subject…

As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws…

Sterile drug manufacturer Eugia SEZ Private Limited’s February FDA inspection resulted in a Form 483 laden with examples of the company failing to follow procedures to prevent microbiological contamination of…

Four units within the FDA have worked together to publish a paper to provide greater transparency on how they will collaborate with the pharmaceutical industry as it develops and deploys…

Despite a potential increase in the risk of death, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted Friday in support of two already approved multiple myeloma CART-T cell treatments in…

The FDA has issued a final guidance on the process generic drug manufacturers can use to correspond with the agency on generic drug development, the agency’s process for responding and…