FDA announces CMC review pilot for drugs with expedited development The US Food and Drug Administration (FDA) announced on 31 October a limited chemistry, manufacturing and controls (CMC) development ...

Officials from the US Food and Drug Administration (FDA) and representatives from the pharmaceutical industry shared insights on the agency’s Chemistry, Manufacturing, and Controls (CMC) Development ...

Developing a new medication can cost over $1 billion, depending on the drug’s complexity and expenses accrued via unsuccessful studies. Considering these costs, an optimized regulatory process is ...

CAMBRIDGE, England & BOSTON--(BUSINESS WIRE)--Bicycle Therapeutics (Nasdaq: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic ...

SARASOTA, FL, July 18, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and ...

FDA’s draft guidance allows sponsors to leverage public and platform knowledge for CMC, nonclinical, and clinical support of ...

In this interview, News-Med talks to Tammy Newbold about the Global Harmonization of Regulatory CMC within Veterinary Medicine. Can you explain what global harmonization of regulatory CMC entails and ...

Silver Spring, MD, June 02, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration (FDA) today issued draft guidance ...

FDA's draft guidance shows gene therapy developers how to use prior knowledge and platform data to accelerate regulatory ...

Genedata, a Danaher company, and the leading provider of enterprise software solutions for biopharma R&D, today announced the launch of Genedata Vico™, an AI–native solution to accelerate CMC ...

The FDA’s press release noted that the guidance supports development of an array of cell and gene therapy products, including ...