This story was updated to reflect additional comments from FDA that were provided after publication of the initial version. Cronyism has crippled America’s pandemic response, enriching undeserving entrepreneurs and politically potent consultants who siphoned funds...

GenScript Biotech Corp. (HKSE:1548) recovered about HK$2.5 billion ($319.3 million) in market cap Sept. 28 after denying all allegations published in a report by short seller Flaming Research. The biotech lost about HK$8 billion ($1...

In today’s environment, no industry is immune from claims of workplace harassment. Allegations can not only tarnish a company’s -- and a board’s -- reputation, and impair shareholder value, but imperil the existence of a...

On Oct. 12, FDA's Cellular, Tissue and Gene Therapy Advisory Committee voted 16-0 that the benefit-risk profile for Luxturna voretigene neparvovec from Spark Therapeutics Inc. (NASDAQ:ONCE) supports the gene therapy's approval to treat biallelic retinal...

Just as FDA was wrapping up the inaugural meeting of its Patient Engagement Advisory Committee, another agency panel unanimously endorsed a gene therapy for a rare vision disorder based in large part on the testimony...

Panelists on FDA's Patient Engagement Advisory Committee (PEAC) concluded the group's inaugural meeting with recommendations for improving recruitment, retention and results communication in clinical trials of medical devices. The panel did not vote on any...

FDA's Cellular, Tissue and Gene Therapy Advisory Committee voted 16-0 that the benefit-risk profile for Luxturna voretigene neparvovec from Spark Therapeutics Inc. (NASDAQ:ONCE) supports the gene therapy's approval to treat biallelic retinal pigment epithelium-specific protein...

A pact with the Centers for Medicare & Medicaid Services for Novartis AG ’s CAR T therapy demonstrates leadership in new value-based drug pricing models. Kymriah tisagenlecleucel represents a milestone for three reasons. Its approval...