Industry News

1. FDA Launches PreCheck Program 8/12/2025

   The program introduces a two-phase approach to enable new U.S. drug manufacturing facilities: The Facility Readiness Phase and the Application Submission Phase.

2. President Trump Demands MFN Prices In Manufacturer Letters 8/7/2025

   President Trump has sent out a letter to 17 major pharmaceutical manufacturers, asking them to commit to lower prices by Sept. 29, 2025, or he plans to deploy every tool in his arsenal to protect American families.

3. Bristol Myers Squibb Forms Immunology Company With Finance Partner 8/5/2025

   The NewCo pipeline will start with three clinical-stage and two phase 1-ready investigational medicines that each target mechanisms in autoimmune diseases.

4. George Tidmarsh Named CDER Director 7/24/2025

   Tidmarsh has over 30 years of experience in biotechnology, clinical medicine, and regulatory science and has authored 143 scientific publications and patents.

5. Sanofi Expands Immunology Portfolio With Blueprint Acquisition 7/24/2025

   Sanofi expanded its portfolio in immunology with the completed acquisition of Blueprint Medicines Corporation.

6. FDA Publishes 200+ CRLs For Increased Transparency 7/16/2025

   The letters were made available to increase transparency and help sponsors reduce similar mistakes in the future.

7. Researchers Switch Up Paracetamol Production With Eco Method 7/2/2025

   Scientists at the University of Edinburgh’s Wallace Lab developed a method to produce paracetamol that can reduce environmental pollution and the industry’s reliance on fossil fuels

8. FDA Addresses U.S. Health Crisis With Voucher Program 7/2/2025

   FDA Commissioner Marty Makary, M.D., M.P.H., tapped into his oncologist experience to launch a new FDA program designed to fast-track the time it takes for important drugs to receive approval and get to patients.

9. Lab Oversupply Is Pushing Leasing, Rent and Relocation Down 7/1/2025

   The landscape of the U.S. pharmaceutical lab market is changing, according to JLL’s U.S. Life Sciences Property Report. In addition to the effort to bring pharma manufacturing back to the U.S. ahead of looming tariffs, an oversupply of space and lower tenant demand in large biopharma markets is dropping leasing rates, rent costs and lease duration, among other changes.

10. CDER's Director Set To Retire Amid FDA Leadership Shuffle 7/1/2025

    Jacqueline Corrigan-Curay, M.D., J.D., announced plans to retire from her position as acting director of CDER, calling the decision "incredibly challenging." Corrigan-Curay is not alone in her decision to leave the FDA, with a number of leaders exiting the agency since January.