New FDA communication introduces a more flexible, risk‑based chemistry, manufacturing, and controls (CMC) framework for cell and gene therapies, including phased data submission to support earlier ...

“Regulatory flexibility must be tailored for cell and gene therapies,” said FDA Commissioner Marty Makary, M.D., M.P.H. “These are common-sense reforms that will address the unique characteristics of ...

The agency outlined the adjustments it's willing to make to "remove barriers and perceived misconceptions" for innovative medicines.

Citius Pharmaceuticals Inc. appointed drug industry veteran Kelly Creighton as executive vice president of chemistry, manufacturing and controls, the company announced Nov. 5. Creighton will be ...

In January 2020, the Food and Drug Administration (FDA) issued a guidance entitled Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications ...

Arm yourself with the tools to write or assemble CMC sections of regulatory submission, to prepare for CMC meetings with FDA, and to avoid non-compliance.

SOUTH SAN FRANCISCO, Calif., June 18, 2025 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS) a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in ...

Deerfield Management, Khosla Ventures, and Sofinnova Partners co-lead Series A fundraise for Excelsior Sciences to accelerate drug discovery and clinical development while supporting pharma reshoring.