FDA rejects Regeneron’s pre-filled Eylea HD syringes amid filling facility woes
Regeneron is planning to re-apply to the FDA with a new pre-filled syringe manufacturing filler in January 2026.
29 October 2025
29 October 2025
Regeneron is planning to re-apply to the FDA with a new pre-filled syringe manufacturing filler in January 2026.
GSK now has the global development and commercialisation rights to the COPD-targeting oligonucleotide, EMP-012.
Another US telehealth company rolls out a microdosing GLP-1RA programme, though experts remain sceptical.
Despite ADX-629 meeting all its endpoints in a Phase II trial, Aldeyra is culling the asset as part of a pipeline reprioritisation.
The joint approach facilitates a smooth transition between drug substance and product stages, optimising timelines.
OTL-200, also referred to as atidarsagene autotemcel, addresses the fundamental genetic issue in MLD.
The foremost geopolitical rivalry between the US and China is increasingly being played out through trade and economic measures.
Merging industry-leading business intelligence & award-winning journalism, this is an unrivalled opportunity for engagement with B2B professionals across a network of 40+ leading media websites.
Steer your business strategy with key data and insights from our latest market research reports and company profiles. Not ready to buy? Start small by downloading a sample report first.
Give your business an edge with our leading industry insights.