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FDA's CDER Rare Diseases Team details ARC Program structure and orphan drug incentives relevant to manufacturers in niche therapeutic markets.
Zealand Pharma opens its 53,600 RSF Cambridge hub, expanding from peptides into biologics and hybrid modalities under its Metabolic Frontier 2030 strategy.
EMA's September Board meeting confirms early-priority implementation of antibiotic exclusivity vouchers, regulatory sandbox, and shortage management under the new EU pharmaceutical legislation.
EMA sets 20 Nov 2026 as the hard deadline for Type IA variations to receive 2026 outcomes, with Type IB procedures due by 30 November.
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