The FDA, as part of its Drug Competition Action Plan, has released final guidance for companies preparing to submit abbreviated new drug applications (ANDAs) to the agency for generic products.…
The FDA issued a warning letter to Aurobindo Pharmaceutical after an inspection of the company’s active pharmaceutical ingredient (API) facility in Hyderabad, India. Source: Drug Industry Daily
A number of sponsors, including some prominent U.S. hospital systems and universities, are still skimping on reporting their trial results as required by federal law, a new analysis shows. Source:…
The FDA has placed a clinical hold that affects five trials of Gilead Sciences’ investigational blood cancer drug, which it just acquired two years ago. Source: Drug Industry Daily
Pfizer is coming under increasing pressure to make its highly effective COVID-19 antiviral treatment Paxlovid more accessible to countries beyond those in North America and Europe. Source: Drug Industry Daily
The FDA has released draft guidance for applicants and holders of an abbreviated new drug application (ANDA) on updating their labeling after revisions to the approved labeling of a reference…
The FDA has slapped Eli Lilly with an Untitled Letter over what it calls a “misleading” and “particularly concerning” ad the company posted on Instagram for its type 2 diabetes…
The FDA has issued draft guidance clarifying the regulatory requirements for collecting and providing portions of official samples of drugs, foods or cosmetics that may be needed for the agency’s…
Sanofi is partnering with Protas, a new UK-based nonprofit organization masterminded by Martin Landray, the leader of the UK’s lauded and highly successful RECOVERY trial, which evaluated multiple treatments for…
Gilead Sciences has yanked two blood cancer approvals for Zydelig (idelalisib) over its failure to conduct FDA-required confirmatory trials. Source: Drug Industry Daily