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A panel of judges from the Federal Circuit Court of Appeals has ruled that two of The Medicines Company’s patents for its anticlotting drug Angiomax are invalid — a win for Hospira, which is planning a generic version of the treatment. Read More
The U.S. government and 11 states are seeking as much as $3.3 billion from Novartis over an alleged kickback scheme involving its Exjade and Myfortic drugs, according to documents filed in the U.S. District Court for the Southern District of New York. Read More
The FDA is cracking down on companies that manufacture or distribute unapproved prescription ear drops labeled to relieve pain, infection and inflammation, warning they will be subject to seizures, injunctions and criminal proceedings. Read More
The FDA Thursday told stakeholders at a public hearing that manufacturers of naloxone may switch their products from prescription-only to over-the-counter as long as they can show that it can be used effectively by consumers guided by product labeling alone. Read More
A federal judge in New Jersey ordered a Hamilton, N.J., company charged with marketing unapproved and misbranded suppositories to destroy its stock and discontinue manufacturing the products. Read More
The full House of Representatives could vote on the 21st Century Cures Act as early as Thursday after the House Rules Committee meets to consider possible amendments to the bill. Read More
Public health advocates called on the FDA Wednesday to expand access to the opioid overdose reversal drug naloxone by converting it from prescription-only to over-the-counter status. Read More
Public health advocates called on the FDA Wednesday to expand access to the opioid overdose reversal drug naloxone by converting it from prescription-only to over-the-counter status. Read More
The FDA is revoking general safety test requirements that are duplicative in biologics licensing applications and proposing to remove two obsolete regulations for the review and reclassification of biologics licensed before July 1972. Read More