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An FDA advisory panel declined Friday to recommend approval of a Pfizer/BioNTech COVID-19 vaccine booster for the general population but it voted unanimously, 18-0, to grant an updated Emergency Use Authorization (EUA) covering boosters in people 65 years and older as well as those at high-risk of progressing to severe disease. Read More
Pfizer has broadened its recall of its smoking cessation drug Chantix (varenicline) to include all 0.5 and 1 mg products because of elevated levels of a nitrosamine contaminant. Read More
The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended nine medicines for approval at its September meeting, including three cancer treatments, a multiple sclerosis drug, an orphan drug, two biosimilars and two generics. Read More
Ahead of a large suit that’s pending with state and local governments across the U.S., Ohio has reached a settlement with Cardinal Health, AmerisourceBergen and McKesson — the three largest opioid distributors — for $808 million, resolving claims that the companies played a role in fueling the opioid epidemic. Read More
The FDA has finalized its Q&A guidance on biosimilars and interchangeable biosimilars, addressing hot topics for developers, including submitting supplements for approved biosimilar applications and for manufacturing changes. Read More
A federal court in Florida issued a consent decree last week to Premier Pharmacy Labs, a compounding pharmacy in Weeki Wachi, prohibiting the company from producing or distributing any drugs until it corrects unsanitary conditions and serious violations of good manufacturing practice. Read More
The alliance outlines numerous concerns with FDA’s plan to construct a national drug packaging identification and tracing system that would link all distributors and allow authorized parties to track any shipment. Read More
The Department of Justice (DOJ) has appealed Purdue Pharma’s $10 billion bankruptcy settlement that resolved thousands of lawsuits and granted the company’s owners, the Sackler family, immunity from future opioid-related legal proceedings. Read More
Under the Biden administration, the FDA has been able to become “boring” again, while the administration looks toward rebuilding the agency’s reputation and its authority after it took a beating under President Trump. Read More
Bamlanivimab and etesevimab are FDA authorized for treating mild-to-moderate COVID-19 in people 12 years and older who are at high risk of progressing to severe disease. Read More