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In its latest move to address the opioid overdose crisis, the FDA is requiring opioid manufacturers to provide prepaid mail-back envelopes to outpatient pharmacies and other dispensers to make it easier for patients to dispose of unused opioids. Read More
In a move to expand its offerings for cell and gene therapy developers, German biotech Sartorius has announced plans to purchase Polyplus for $2.6 billion, gaining access to the Strasbourg, France-based company’s viral vector production technology. Read More
Masimo’s Opioid Halo system — the first FDA-authorized monitoring solution for detecting opioid-induced respiratory depression — has been granted a De Novo authorization for sale over the counter and by prescription. Read More
FDAnews welcomes to its new editorial advisory board seven thought leaders with deep experience in the drug, device and clinical research industries. These seven experts are at the top of their field and will help provide our readers with even greater depth and analysis of drug and device industry news and trends. Read More
Global Pharma Healthcare — the Chennai, India-based drugmaker that has issued two recent high-profile recalls of its eye drops for potential contamination — drew an 11-observation Form 483 from the FDA citing lax sterility practices and other deficiencies. Read More
A federal jury has ordered Novartis’ Sandoz subsidiary to pay $39 million in damages to Allergan and Duke University for infringement of patent rights for Allergan’s eyelash-enhancing therapy Latisse (bimatoprost). Read More
Illumina said it will appeal a Federal Trade Commission (FTC) order to divest itself of Grail — developer of the Galleri early detection liquid biopsy test to screen for multiple types of cancer. Read More
In this two-part series, FDAnews examines the dramatic impact of artificial intelligence (AI) on medical devices and the significant challenges it presents for regulators. Part 1 is an overview of the use of AI in medical devices.Read More
A trio of Republicans on the House Energy and Commerce Committee have called on the FDA to explain what steps the agency is taking to address persistent drug shortages and supply chain vulnerabilities. Read More
The U.S. Solicitor General is asking the Supreme Court to consider a case — Teva Pharmaceuticals v. GlaxoSmithKline (GSK) — that highlights the pharmaceutical industry’s ongoing dispute over “skinny labeling.” Read More
The FDA has granted Pixium Vision Breakthrough Device status for its Prima System, an investigational device for restoring partial vision for people with blindness caused by dry age-related macular degeneration (AMD). Read More