RegulatoryGuideline · final
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with tracked changes
🇪🇺 EMA · Tue 06 Oct 2026
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with tracked changes
Official guideline text: EMA ↗
Brief written by VigiEye from the company's press release. Claims are the company's own. AI-assisted; check the source before acting.
More Regulatory
All →
RegulatoryCompany releaseBeyondSpring wins FDA Fast Track for plinabulin-docetaxel in post-immunotherapy NSCLC as cash dwindles to $0.6M
BeyondSpring, Inc. · Fri 13 Nov 2026
RegulatoryCompany releaseImricor starts US launch of NorthStar iMR system after paediatric FDA clearances
🇺🇸 Imricor Medical Systems, Inc. · Fri 13 Nov 2026
RegulatoryCompany releaseBeyond Air reports record $2.3M quarterly revenue as FDA reviews second-generation LungFit PH
🇺🇸 Beyond Air, Inc. (XAIR) · Fri 13 Nov 2026
RegulatoryCompany releaseFDA sets 10 March 2027 goal date for Intellia's one-time hereditary angioedema gene-editing therapy
🇺🇸 Intellia Therapeutics, Inc. (NTLA) · Fri 13 Nov 2026
RegulatoryCompany releaseBeyondSpring wins FDA Fast Track for plinabulin plus docetaxel in post-immunotherapy NSCLC
🇺🇸 BeyondSpring Inc. (BYSI) · Fri 13 Nov 2026
RegulatoryCompany releaseFDA grants NeOnc Type B meeting on accelerated approval path for intranasal NEO100
🇺🇸 Neonc Technologies Holdings, Inc. (NTHI) · Fri 13 Nov 2026