An announcement from Glenmark Pharmaceuticals Limited ( ($IN:GLENMARK) ) is now available. Glenmark Pharmaceuticals Limited has received a warning ...

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...

The FDA, under Health Secretary Robert F. Kennedy Jr., has taken another step to question the safety of Covid-19 vaccines.

The recall will remain active until the FDA and Carley's Inc. have resolved the labeling issue and ensured that all misbranded products are removed from the market. Consumers who have purchased ...

The U.S. FDA informed two pharmaceutical companies that it must update its warning labels about potential risks associated with the vaccine.

The FDA has approved its requested updated versions of expanded warning labels for COVID-19 vaccines. As Healio previously reported, the FDA sent letters to Moderna and Pfizer/BioNTech in April, ...

The warning letters deal with a range of violations involving items from personal hygienic products to mismarketed analgesics.

AACE pharmaceuticals was slammed in a warning letter by the FDA that cited significant violations by its contract manufacturer Brassica Pharma, including sanitary conditions and made up lab records.