Novo Nordisk's Bloomington facility received an OAI label from the FDA due to compliance issues, including contamination by extrinsic particles. Scholar Rock's drug application was rejected due to ...

Slapped with the most severe post-inspection classification, the state of Novo Nordisk’s Indiana manufacturing site could ...

While a new facility setup program aimed at encouraging onshoring received a positive reception at a recent meeting, industry ...

The FDA has declared a Novo Nordisk plant, key to drug manufacturing for some biotechs, out of compliance, which could delay ...

Applicants can request this priority review by following the procedures outlined in FDA’s Manual of Policies and Procedures ...

Marketing and manufacturing practices for compounded GLP-1RA drugs have come under FDA scrutiny, prompting policy changes.

Rising tariffs and regulatory shake-ups are reshaping how drugmakers plan, design and deliver the next generation of U.S.

Generic drugs are the same as brand name drugs in terms of ingredients, safety, and effectiveness. However, generic drugs are ...

U.S. regulators on Monday authorized emergency use of the first experimental antibody drug for COVID-19 in patients who are not hospitalized but are at risk of serious illness because of their age or ...

U.S. drug inspectors uncovered serious quality control problems at an Eli Lilly and Co pharmaceutical plant that is ramping up to manufacture one of two promising COVID-19 drugs touted by President ...

The United States has grown its dependent on foreign drug supplies from China and India,, causing a national security and ...

The FDA has issued a complete response letter (CRL) to a new drug application (NDA) for Dasynoc for the treatment of chronic ...