The Food and Drug Administration is preparing to launch an agency wide generative artificial intelligence system by the end ...

GenScript, a global leader in life science research tools and services support, has expanded its mRNA synthesis and ...

Dr Reddys Laboratories said that the United States Food & Drug Administration (US FDA), post a GMP inspection, has issued a Form 483 with 2 observations to the company's Telangana-based manufacturing ...

U.S. FDA issues Form 483 with 2 observations to Dr. Reddy's Laboratories' API manufacturing facility in Miryalaguda.

With the application submission deadline ending on 11 May, there was a flurry of applications, given that failure to meet the ...

The United States Food & Drug Administration has completed a GMP inspection at Dr. Reddy's Laboratories Ltd's API Middleburgh ...

Q1 2025 Management View CEO Sean P. Nolan highlighted "significant regulatory and clinical progress" in the TSHA-102 Rett syndrome program, citing written alignment from the FDA on pivotal Part B ...

Zhong Li’s extensive history with the FDA offers crucial lessons on how companies in the pharmaceutical and biopharmaceutical sectors should approach inspection preparedness.  As an experienced FDA ...

Health and Human Services Secretary Robert F. Kennedy Jr. said the timeline to see U.S. drug prices fall to the same level as those seen in European countries will largely depend on how ...

President Donald J. Trump issued Executive Order (“EO”) 14293 entitled Regulatory Relief to Promote Domestic Production of ...

May 8 (UPI) --The Food and Drug Administration on Thursday announced what it called an aggressive agency-wide artificial intelligence adoption timeline, as well as a new AI tool to help scientists ...

Investing.com -- In a groundbreaking move, FDA Commissioner Martin A. Makary, M.D., M.P.H., announced today a bold plan to expand the use of artificial intelligence (AI) across all FDA centers by ...