The US Pharmacopeia’s 2025 annual drug shortages report found that while the total number of shortages declined by 23% in ...

CAI's Jon Thompson details how digital twins cut cleanroom commissioning time by up to 30% and accelerate GMP deviation ...

At CPHI Americas 2026, PharmTech spoke with Dr. Molly Klote, president and CEO, Klote Medical Research Advisors, and ...

According to the USP report, the duration of drug shortages increased to 5.3 years in 2025. This is a result of new shortages ...

The EMA’s annual report shows the agency approved 104 human drugs in 2025 that included first-in-class and first-in-indication therapies. The European Medicines Agency (EMA) announced the publication ...

GSK’s $124/share all-cash offer values Nuvalent at $10.6B, targets Q3 2026 close, and is funded via new/existing debt facilities plus cash, contingent on regulatory and tender conditions. Zidesamtinib ...

Q5A (R2) expects sponsors to build and justify a risk-based viral safety from overlapping controls: what you prevent from ...

The transition from a breakthrough molecule to a scalable product is the industry's greatest challenge, noted Meyer. As such, ...

Sponsors are expected to justify relevance and applicability when relying on prior CMC, nonclinical, or clinical information to increase review efficiency. Platform knowledge can derive from internal ...

Data integrity, impurity characterization, and stability requirements are key focus areas in drug substance testing, with advanced analytical technologies enhancing accuracy. Newer modalities, ...

Johnson & Johnson’s Firelink degrader antibody conjugate strategy seeks tumor-selective delivery of degraders for KRAS-driven solid tumors, potentially overcoming toxicity and efficacy ceilings of ...

Tailored EMA and FDA pathways may waive comparative efficacy studies when analytical and functional similarity are convincingly demonstrated, while preserving clinical confirmation for ...