Defining the steps involved in a successful technology transfer process would benefit biopharma, say the researchers behind a “generic” blueprint intended to help drug makers move more easily from ...

A push to reshore some drug production and progress in advanced manufacturing technologies have been prominent trends this year, industry leaders say.

Drug Substance manufacturing is a critical component of pharmaceutical production, requiring precise processes, rigorous quality control, and innovative solutions to overcome various challenges. From ...

President Trump wants pharmaceutical production to return to the United States. A shuttered factory in Louisiana shows how hard that will be for generic medicines. Dr. Reddy’s, an Indian generic ...

The U.S. Food and Drug Administration has awarded the National Institute for Pharmaceutical Technology and Education a grant worth up to $35 million over the next five years to improve drug ...

While much of the conversation around the Trump administration’s potential pharmaceutical import tariffs has leaned heavily toward branded drugmakers, generic medicines and the companies that ...

Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s ...

The Wegovy pill's approval signifies a shift from injectable to oral dosage forms, driven by patient preference for ...

An international team of researchers led by the University of California San Diego has developed a new strategy to enhance ...

It could be years before a cell therapy from Nkarta reaches autoimmune disease patients in the market, but CEO Paul Hastings still thinks about the impact of pharmaceutical tariffs here and now. With ...

Learn how an Abbreviated New Drug Application (ANDA) helps generic drugs get FDA approval without clinical trials, ensuring safety and bioequivalence with brand-name drugs.

A new analysis found that nearly 700 drugs approved for use in the United States depend on chemicals solely produced in China. By Rebecca Robbins For years, Democrats and Republicans have sounded the ...