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

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 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 ...

Orforglipron is the first new molecular entity cleared under the FDA's Commissioner's National Priority Voucher (CNPV) pilot ...

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

In news this week, Merck’s multi-billion-dollar acquisition of Terns Pharmaceuticals reinforces the industry’s focus on ...

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

Scale-up involves increasing pump sizes, reactor volumes, and flow rates—but the process control logic and system ...

The 2023 revision of Annex 1 of the European Union’s good manufacturing practice (GMP) guidelines 1 represents a fundamental shift in expectations for sterile manufacturing. Reg ...

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

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