Leaders from the world of cell and gene therapy shared their personal stories and policy recommendations in an extraordinary ...

Medable has launched a digital-first long-term follow-up (LTFU) model intended for cell and gene therapy (CGT) trials, aiming ...

Gene therapy experts and advocates warning of the sector’s many challenges found a receptive audience in FDA leadership at a ...

Within the guidance, the FDA restated its “commitment to increase efficiency in the development of CGT products”, which it said continue to grow at a fast rate in the US, with a range of ...

Seven years after the FDA’s landmark approval of a gene therapy, clearing the way for leukemia drug Kymriah, 1 the cell and gene therapy (CGT) sector is now entering a new era. Driven by significant R ...

Medable Inc., a leading technology platform provider for decentralized clinical trials, today unveiled its digital-first Long-Term Follow-Up (LTFU) model for cell and gene therapy (CGT) trials.

The FDA has granted our Prucalopride Tablets a Competitive Generic Therapy (CGT) designation, with 180-day exclusivity. ANI continues to hold the second-highest number of CGT approvals in the U.S ...

The FDA has granted Prucalopride Tablets a Competitive Generic Therapy (CGT) designation, with 180-day exclusivity. U.S. annual sales for Prucalopride Tablets total approximately $168.0 million ...

The FDA has granted our Prucalopride Tablets a Competitive Generic Therapy (CGT) designation, with 180-day exclusivity. ANI continues to hold the second-highest number of CGT approvals in the U.S ...