A new drug application (NDA) and a biologics license application (BLA) have been resubmitted and accepted by the FDA for ...

"Providing clarity around modern statistical methods will help sponsors bring more cures and meaningful treatments to ...

Strategic Priorities and the Future of Life Sciences' Featuring Serina Therapeutics’ CEO - Wednesday, February ...

FDA’s new PreCheck pilot streamlines building US pharma manufacturing plants with earlier guidance and faster reviews. Read more here.

Mayo Clinic’s Chelsee Jensen, PharmD, discusses FDA policy changes, biosimilar development hurdles, denosumab lessons, and ...

The FDA launched PreCheck pilot program to strengthen U.S. drug supply chain by improving regulatory predictability.

It can take a decade and $2 ‍billion to bring a new drug to market, pharmaceutical ​companies say. Many, including Eli Lilly, which has partnered with leading chipmaker Nvidia, are betting AI can also ...

At the highest levels of the FDA, questions remain about which officials have the legal authority to sign off on drugs cleared under the Commissioner’s National Priority Voucher program, which ...

Jan 15 (Reuters) - The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration's new fast-track program after agency scientists flagged safety and ...

The MarketWatch News Department was not involved in the creation of this content. TUSCALOOSA, Ala., Jan. 06, 2026 (GLOBE NEWSWIRE) -- PridCor Therapeutics, a clinical-stage biopharmaceutical company ...

The FDA appointed George Tidmarsh, MD, PhD, to be the nation's top drug official in July. The Center for Drug Evaluation and Research (CDER) has since cycled through another two leaders in 5 months.

Sanofi SNY announced that the FDA has issued a complete response letter (CRL) to its new drug application (NDA), seeking approval for its investigational Bruton's tyrosine kinase (BTK) inhibitor, ...