The evolution of microbiology testing within contamination control strategies reflects broader changes across the ...

The FDA approved the first generic dapagliflozin tablets, opening a competitive US market for pharma manufacturers and generic-drug developers.

In part 2 of a 2-part interview,Susan Schniepp, Regulatory Compliance Associates Inc., discusses the evolving relationship ...

Digital predictive modeling is being used to simulate extreme distribution conditions and prioritize mitigation, but hybrid ...

Biocon launches two FDA-approved interchangeable denosumab biosimilars in the US, targeting osteoporosis and bone metastasis in a $5B market.

Susan Schniepp, Regulatory Compliance Associates Inc., discusses digital twins and AI in pharma, focusing on data integrity, human-in-the-loop roles, and evolving machine learning risks. In part 1 of ...

Indirect data suggest oral semaglutide outperforms orforglipron on weight loss and tolerability, with patients also favoring its treatment profile.

Proprietary capsid engineering supports comparable cardiac gene delivery at 5–10-fold lower vector doses, potentially improving batch economics, easing purification constraints, and widening ...

Terry Novak, CEO of Benuvia, explores how pharmaceutical and biotech companies can mitigate development risks and accelerate ...

Lilly licenses Insilico's AI drug discovery platform in a deal worth up to $2.75B, signaling a shift in how novel ...

Susan Schniepp, Regulatory Compliance Associates Inc., explains how flexibility, right-sized SOPs, and transparency keep compliance simple. In part 3 of a 3-part interview, Susan Schniepp, Regulatory ...

EMA approved Johnson & Johnson’s daratumumab SC for self-administration, Europe’s first oncology injectable to offer this ...