MDR, MDSAP, and FDA audits demand rigorous preparation, lifecycle traceability, and risk-based compliance for global market ...

A structured data ownership model—rooted in ICH GCP principles, supported by MHRA and FDA interpretations, and documented in validated system specifications—will enable sponsors to maintain compliance ...

The FDA has issued a second complete response letter to Atara Biotherapeutics for its biologicals license application of ...

Catalent’s sweeping workforce reductions within its Maryland gene therapy manufacturing operations were preceded by two FDA inspections in April that resulted in red flags from the agency, FDA filings ...

The US Food and Drug Administration approved Novo Nordisk's weight-loss pill on Monday, giving the Danish drugmaker a leg up in the race to market a potent oral medication for shedding pounds, Reuters ...

The US Food and Drug Administration has approved a daily pill version of Novo Nordisk’s weight-loss drug Wegovy, according to the pharmaceutical giant. The approval marks the first pill of its kind to ...

If you took the warning label that comes with your birth control and tossed it right in the trash, you wouldn’t be alone. After all, every medication comes with a risk of side effects, and those ...

The American depository receipts of Novo Nordisk rose after the tablet formulation of the company's GLP-1 weight loss drug received approval from the Food and Drug Administration. Novo Nordisk's ADRs ...

Volaris president and CEO Enrique Beltranena stated: "The economies of scale and expanded distribution capacity will allow us to compete even more effectively in domestic and international markets by ...

Regulators at the U.S. Food and Drug Administration on Monday gave the green light to a pill version of the blockbuster weight-loss drug Wegovy, the first daily oral medication to treat obesity. The ...