In today’s Pharmaceutical Executive Daily, the FDA moves to limit regulation of non-medical fitness wearables, industry ...
The "Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century--A Risk Based Approach" initiative was ...
“Orforglipron and retatrutide from Eli Lilly exemplify the next generation of metabolic therapies: oral formulations that promise improved adherence, triple-hormone mechanisms that deliver superior ...
Vanda Pharmaceuticals announced it received a decision letter from the FDA’s Center for Drug Evaluation and Research (CDER) stating that the supplemental New Drug Application (NDA) for Hetlioz ...
Eli Lilly and Company and Ventyx Biosciences entered into a definitive agreement under which Eli Lilly will acquire Ventyx in ...
PE: How is AI supporting clinical trial design? Schwab: We have a hit a new era of clinical trial design. Up until 2024, ...
In today’s Pharmaceutical Executive Daily, Amgen announces an $840 million acquisition of Dark Blue Therapeutics, GSK enters ...
FDA’s decision to limit regulations of non-medical grade wearables marks a notable shift toward regulatory restraint in digital health. FDA announced its plan to stop subjecting non-medical grade ...
GSK announced it has entered a multi-year strategic collaboration agreement with Helix aiming to drive the development of ...
The Skinny Labels, Big Savings Act was introduced on January 9 in an effort to provide “a statutory safe harbor from patent ...
True patient-centricity will drive commercial success as CGT moves beyond first-generation therapies. Current timelines in CGT, from diagnosis to treatment, can exceed six months, often compounded by ...
Angela Schwab, founder and CEO of Trialynx, discusses the current state of AI in the pharmaceutical industry and why it’s ...
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