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

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 ...

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

EMA, African Medicines Agency, and African national regulators initiated joint oversight to accelerate Ebola clinical trials ...

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, ...

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 ...

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, ...

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

Erez Israeli, chief executive officer of Dr. Reddy's Laboratories, provides insight on the company’s generic version of semaglutide, which entered the Canadian market in May 2026.

CMC teams can align with Q5A (R2)’s updated guidance to shorten testing timelines and strengthen assurance of participant ...