FDA warns Canada’s Sante Manufacturing about CGMP issues found in an agency review of requested records detailing the firm’s manufacturing of over-the-counter drugs.
Eli Lilly reports positive Phase 3 results for its BTK inhibitor Jaypirca (pirtobrutinib) in combination with venetoclax and rituximab.
FDA warns Canada’s Sante Manufacturing about CGMP issues found in an agency review of requested records detailing the firm’s manufacturing of over-the-counter drugs.
Eli Lilly reports positive Phase 3 results for its BTK inhibitor Jaypirca (pirtobrutinib) in combination with venetoclax and rituximab.
Significant operational hurdles remain before FDA's Plausible Mechanism Framework can be broadly implemented, according to a commentary published by Steven Ringel, founder and chief executive of Nome Therapeutics. The framework is intended to establish a regulatory pathway for highly individualized therapies where conventional clinical trial requirements may not be feasible. Under the framework, sponsors may be able to demonstrate efficacy through biological proof of concept, including evidence that a therapy addresses a disease
FDA increases scrutiny of telehealth companies marketing compounded drugs, warning that some firms are making false or misleading claims about compounded GLP-1 weight-loss treatments and other medications.
