Susan Schniepp, Regulatory Compliance Associates Inc., discusses siloed pharma data being a hidden risk, with AI as a ...

The biopharmaceutical industry is undergoing a significant transformation as dynamic regulatory and quality frameworks evolve ...

New US pharmaceutical tariffs reach up to 100%, with exemptions for companies that strike pricing deals or commit to domestic manufacturing.

The European Medicines Agency’s CHMP recommended five new drugs for approval at its March 2026 meeting, including novel ...

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

EMA states that reduction in animal testing will be gradual. The first qualification opinion for a NAM used in toxicity ...

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

Ultimately, Schniepp's message is clear: a robust quality system is not merely a regulatory obligation, it is a sound business investment. By catching problems early and consistently, companies can ...

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

During its March 2026 meeting, the agency’s Committee for Medicinal Products for Human Use approved treatments for Bacillus ...

Eli Lilly has agreed to acquire Centessa Pharmaceuticals in a transaction valued at approximately $6.3 billion upfront, with ...

Michelle Dennis, QC Microbiology Application Specialist with MilliporeSigma and member of the PDA Week 2026 planning ...