List of centrally authorised products with safety-related changes to the product information

List of centrally authorised products with safety-related changes to the product information

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.

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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