The FDA is asking stakeholders to suggest structural endpoints for use in trials of medical products aimed at treating the root cause of osteoarthritis. Source: Drug Industry Daily

Citing data integrity concerns, the FDA hit Kyowa Hakka Bio with another warning letter for repeat violations at its Hofu, Yamaguchi facility. The agency issued a previous warning to the…

Under a voluntary initiative set to take effect this month, Oklahoma will introduce value-based drug purchasing for Medicaid, only fully compensating manufacturers of drugs that deliver the promised results. Source:…

CVS and Rite Aid filed an antitrust suit accusing AbbVie of mounting “sham” patent lawsuits against two generic manufacacturers to protect its testosterone replacement drug AndroGel from competition. Source: Drug…

In the first 100 days since the Trump administration issued its American Patients First blueprint, 15 drug companies have cut list prices, reversed planned price hikes or called for price…

Janssen and Takeda called for more flexibility in the FDA’s draft guidance for sponsors of drugs that treat major depressive disorder (MDD). Source: Drug Industry Daily

The FDA cited API manufacturer Shandong Zouping Dazhan New Materials after a January inspection of the firm’s Shandong facility revealed significant testing and other violations. Source: Drug Industry Daily

Sponsors conducting nonclinical radiopharmaceutical diagnostic drug trials can seek waivers for specific nonclinical pharmacology or toxicology studies, according to final guidance from the FDA. Source: Drug Industry Daily

The FDA released final guidance Monday on quality attributes sponsors should consider for chewable tablets, suggesting they should be easy to chew, have a “bearable” taste and disintegrate easily. Source:…

A Johns Hopkins University panel has released guidelines for prescribing opioids after 20 common surgical procedures, noting that post-op overprescribing been a major driver of the nation’s addiction crisis. Source:…