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The FDA has again updated guidance on its criteria for refusing to receive an ANDA, providing a broader definition for major deficiencies and downgrading four major deficiencies to minor ones in order to make requirements less burdensome for industry. Read More
Four pharmaceutical companies that dramatically raised prices for decades-old, off-patent drugs all followed a series of steps designed to create and defend a monopoly on the product — allowing them to control the product’s prices with little, if any, market interference, according to a Senate committee investigation. Read More
The FDA plans to require risk evaluation and mitigation strategies for opioid analgesics — including immediate, extended-release and long-acting formulations — to ensure the benefits outweigh the risks of misuse, abuse, addiction, overdose and death. Read More
Juno has filed a lawsuit against Kite Pharma for the alleged infringement of eight patent claims covering a cancer immunotherapy that uses a chimeric T cell receptor. Read More
Spain’s Agency of Medicines and Medical Devices has ordered Madrid vaccine maker Angulema to suspend manufacturing and recall drug batches over GMP deficiencies. Read More
The FDA issued X2 Zero a warning letter, after investigators observed several GMP violations at the company’s Texas facility and unspecified active ingredients in its supplements. Read More