An FDA advisory committee voted Thursday that Infocare’s NDA for stannsoporfin injection’s overall risk-benefit profile does not support the drug’s approval. Source: Drug Industry Daily

The administration is considering whether to revisit if drug companies’ rebates should be allowed safe harbor from anti-kickback laws in an effort to help curb rising healthcare costs, FDA Commissioner…

The FDA issued a Form 483 to AbbVie for its handling of complaints and samples. Source: Drug Industry Daily

Fresenius claimed it discovered “blatant fraud at the very top level of Akorn’s executive team [and] stunning evidence of blatant and pervasive data integrity violations,” after it had agreed to…

The FDA Antimicrobial Drugs Advisory Committee voted 15-0 that Achaogen’s NDA for plazomicin proved safety and effectiveness for complicated urinary tract infections in patients with limited or no treatment options.…

The FDA finalized guidance on assessing user fees under PDUFA VI — covering fiscal years 2018 through 2022 — describing the new fee structure and the types of fees organizations…

The FDA hit drug compounder Fusion IV with a warning letter after an agency inspection found numerous problems at its outsourcing facility including the failure to meet conditions for section…

In the latest tussle over lucrative patents covering the revolutionary gene-editing technology CRISPR-Cas9, an appeals judge for the U.S. Court of Appeals for the Federal Circuit said she would likely…

In what Regeneron CEO Len Schleifer called a “paradigm-shifting agreement,” Sanofi and Regeneron sealed a deal with the pharmacy benefit manager Express Scripts cutting the price of their cholesterol drug…

In a 17-0 vote, the FDA’s Antimicrobial Drugs Advisory Committee voted that the data show a favorable risk-benefit profile for TPOXX (tecovirimat) for its proposed indication for treating smallpox caused by…