Joseph Keenan

Novo Nordisk landed in hot water with the FDA following an inspection at one of the drugmaker's key semaglutide and insulin manufacturing plants this past spring.

The U.S. unit of Indian drugmaker Dr. Reddy's Laboratories is recalling 331,590 bottles of cinacalcet tablets used to treat hyperparathyroidism due to the presence of a known carcinogen.

The Government Accountability Office (GAO) issued a 67-page report that urges the FDA to begin implementing more aggressive steps to attract and

Unexo Life Sciences, an Indian drugmaker that manufactures a medicated patch for pain relief, has been hit with a

Indian drugmaker Lupin is recalling more than 600,000 bottles of the high blood pressure and heart failure drug ramipril due to the presence of an active pharmaceutical ingredient (API) that came from an unapproved vendor.

Indian drugmakers Aurobindo, Glenmark and Zydus have issued separate sweeping drug recalls over issues pertaining to impurities and labeling.

CDMO giant Lonza unveiled plans to expand hard gelatin capsule production capacity at plants in India and China a week after announcing its intent to shed its capsules and health ingredients (CHI) division.

Viatris disclosed that its manufacturing facility in Indore, India, was issued a warning letter from the FDA, which banned 11 products that are produced at the site from being imported into the U.S. for distribution.

Astellas Pharma and Endo subsidiary Endo USA issued voluntary recalls for products they manufacture over concerns of empty tablets and unapproved ingredients, respectively.

Anthem Biosciences, an India-based CDMO, submitted a filing (PDF) at the end of 2024 to announce its plans for a 33.95 billion rupee ($397 million) public offering.