Methodological Principles for the Assessment of Section 5.1 of the Summary of Product Characteristics

Methodological Principles for the Assessment of Section 5.1 of the Summary of Product Characteristics

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 release

BeyondSpring wins FDA Fast Track for plinabulin-docetaxel in post-immunotherapy NSCLC as cash dwindles to $0.6M

BeyondSpring, Inc. · Fri 13 Nov 2026

RegulatoryCompany release

Imricor starts US launch of NorthStar iMR system after paediatric FDA clearances

🇺🇸 Imricor Medical Systems, Inc. · Fri 13 Nov 2026

RegulatoryCompany release

Beyond Air reports record $2.3M quarterly revenue as FDA reviews second-generation LungFit PH

🇺🇸 Beyond Air, Inc. (XAIR) · Fri 13 Nov 2026

RegulatoryCompany release

FDA 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 release

BeyondSpring wins FDA Fast Track for plinabulin plus docetaxel in post-immunotherapy NSCLC

🇺🇸 BeyondSpring Inc. (BYSI) · Fri 13 Nov 2026

RegulatoryCompany release

FDA grants NeOnc Type B meeting on accelerated approval path for intranasal NEO100

🇺🇸 Neonc Technologies Holdings, Inc. (NTHI) · Fri 13 Nov 2026