Actualités
FDA reinstates Vinay Prasad to lead CBER as gene therapy safety concerns spotlight regulatory challenges in biotech manufacturing.
Thermoplastic elastomers (TPE) offer a PFAS-free solution for stoppers in parenteral packaging, ensuring a safer and more sustainable product.
For the first target addressed in the partnership, the two companies reported the successful delivery of AI-designed, functional antibody leads.
The agency’s new program is designed to increase regulatory predictability and streamline review of domestic manufacturing facilities.
Experts from LGM Pharma and Rockwell Automation share their thoughts on what makes tech transfer effective, where processes could be improved, and why certain development and manufacturing decisions ...
Jonathan D. Grinstein, PhD, Manfred Scholz, PhD, and Erik Wiklund, PhD, go behind the headlines to address a shifting policy landscape and what it means for the future of chronic disease, diagnostics, ...
Orforglipron showed clinically meaningful results at 72 weeks, after three doses, in a pool of more than 3000 adults.
The investment will expand the company’s manufacturing and packaging capabilities at its Maple Grove, Minn. site, which Bora acquired in 2024 with its acquisition of Upsher-Smith Laboratories.
Jerry Keybl, senior vice-president, Biopharma Products and Strategy, Avantor, discusses innovations in biomanufacturing and recalls his impressions of INTERPHEX 2025 held this past April.
ESTEVE CDMO's acquisition of Regis Technologies expands its US API contract development and manufacturing services, enhancing early-stage development capabilities. The acquisition adds process R&D, ...
A new nuclear magnetic resonance method reveals real-time, coordinated changes in nanoemulsion drugs, improving noninvasive analysis and regulatory evaluation.
The company’s FDA-approved first generic sertraline capsules secured a 180‑day exclusivity period, highlighting strategic generic development pathways.
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